US LAWS, STATUTES & CODES ON-LINE

For most effective results, cattle should be treated as soon as possible after heel-fly activity ceases. Host-parasite reactions such as bloat, salivation, staggering and paralysis may sometimes occur when cattle are treated while the common cattle grub (Hypoderma lineatum) is in the gullet, or while the northern cattle grub (H. bovis) is in the area of the spinal cord. Cattle should be treated before these stages of grub development. Consult your veterinarian, extension livestock specialist, or extension entomologist regarding the timing of treatment. If it is impossible to determine the area from which the cattle came and/or exact stage of the grubs, it is recommended that the cattle receive only a maintenance ration of low-energy feed during the treatment period. This lessens the likelihood of severe bloat which may occur in cattle on full feed when the common grub is killed while in the gullet. A second application is required for animals heavily infested with lice or for those which become reinfested. A second application should be made no sooner than 35 days after the first treatment.

(iii) Do not treat dairy cattle of breeding age; calves less than 3 months old; sick, convalescent, or severely stressed livestock.

(iv) Do not treat cattle for 10 days before or after shipping, weaning, dehorning, or after exposure to contagious or infectious diseases.

(v) Do not slaughter within 45 days of treatment.

(d) Specifications. (1) The drug is a solution containing either 5.6 or 13.8 percent fenthion. Each concentration is available in 2 volumes which are contained in single-dose applicators.

(2) Sponsor. See No. 000859 in §510.600(c) of this chapter.

(3) Special considerations. Fenthion is a cholinesterase inhibitor. Do not use this product on dogs simultaneously with or within 14 days before or after treatment with or exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals. Do not use with flea or tick collars.

(4) Conditions of use—(i) Amount. Four to 8 milligrams per kilogram of body weight.

(ii) Indications for use. For flea control on dogs only.

(iii) Limitations. Apply the contents of the proper size, single-dose tube directly to one spot on the dog's skin. Frequency of repeat treatments depends upon rate of flea reinfestations. Do not use more often than once every 2 weeks. Treatment at 2-week intervals is not to exceed 6 months. Do not use on puppies under 10 weeks of age. Do not use on sick, stressed, or convalescing dogs. Safe use in breeding males has not been established. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 41 FR 16656, Apr. 21, 1976; 42 FR 58741, Nov. 11, 1977; 45 FR 62425, Sept. 19, 1980; 50 FR 19169, May 7, 1985]

(a) Specifications. Each milliliter of ophthalmic preparation contains 0.10 milligram flumethasone, 5.0 milligrams neomycin sulfate (3.5 milligrams neomycin base), and 10,000 units of polymyxin B sulfate, with or without hydroxypropyl methylcellulose.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount—(i) Preparation containing hydroxypropyl methylcellulose. Dogs: 1 to 2 drops per eye, every 6 hours.

(ii) Preparation without hydroxyproply methylcellulose. Dogs and cats: 2 to 3 drops per eye, every 4 hours.

(2) Indications for use. Treatment of the inflammation, edema, and secondary bacterial infections associated with topical ophthalmological conditions of the eye such as corneal injuries, incipient pannus, superficial keratitis, conjunctivitis, acute nongranulomatous anterior uveitis, kerato- conjunctivitis, and blepharitis.

(3) Limitations. (i) In treating ophthalmological conditions associated with bacterial infections, the drug is contraindicated in those cases in which microorganisms are not susceptible to the antibiotics incorporated in the drug.

(ii) The drug is contraindicated in infectious tuberculous lesions of the eye, early acute stages of viral diseases of the cornea and conjunctiva, herpes simplex lesions of the eye, and fungal infections of the conjunctiva and eyelids.

(iii) The usual precautions and contraindications for corticosteroids and adrenocorticoids are applicable with this drug. Corticosteroids may inhibit essential inflammatory responses intrinsic to the fundamental healing mechanism. Adrenocorticoid compounds have been reported to cause an increase in intraocular pressure. Intraocular pressure should be checked frequently. Ocular reexaminations should be made at frequent intervals during long-term therapy.

(iv) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[44 FR 16012, Mar. 16, 1979, as amended at 61 FR 5507, Feb. 13, 1996]

(a) Specifications. The drug contains 0.025 percent fluocinolone acetonide.

(b) Sponsor. See No. 099207 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is indicated for the relief of pruritus and inflammation associated with certain superficial acute and chronic dermatoses in dogs. It is used in the treatment of allergic and acute moist dermatitis and for the relief of superficial inflammation caused by chemical and physical abrasions and burns.

(2) A small amount is applied to the affected area two or three times daily.

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 62 FR 40932, July 31, 1997]

(a) Specifications. The drug contains 0.01 percent fluocinolone acetonide in propylene glycol with citric acid.

(b) Sponsor. See No. 099207 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is indicated for the relief of pruritus and inflammation associated with otitis externa and certain superficial acute and chronic dermatoses in the dog. It is also indicated for the relief of pruritus and inflammation associated with acute otitis externa and certain superficial acute and chronic dermatoses in the cat.

(2) A small amount of solution is applied to the affected area 2 or 3 times daily.

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 62 FR 40932, July 31, 1997]

(a) Specifications. The drug contains 0.025 percent fluocinolone acetonide and 0.5 percent neomycin sulfate (0.35 percent neomycin base).

(b) Sponsor. See No. 099207 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is used in the relief of pruritus and inflammation associated with superficial acute and chronic dermatoses in dogs. It is used in the treatment of such conditions as allergic and acute moist dermatoses and nonspecific dermatoses in dogs. It is used in the treatment of wound infections in dogs and cats.

(2) A small amount is applied to the infected area two or three times daily.

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 62 FR 40932, July 31, 1997]

(a) Specifications. Each milliliter of solution contains 0.01 percent fluocinolone acetonide and 20 percent dimethyl sulfoxide with propylene glycol and citric acid.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is used in dogs for the relief of impaction commonly present in apparently normal anal sacs, for the reversal of inflammatory changes associated with abnormal anal sacs, and to counteract the offensive odor of anal sac secretions.

(2) It is administered by instillation of 1 to 2 milliliters into each anal sac following expression of anal sac contents. It may be necessary to repeat treatment at 60-day intervals to maintain an odor-free state. The total dosage used should not exceed 2 milliliters per anal sac per treatment.

(3) For use only by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 61 FR 5507, Feb. 13, 1996]

(a) Specifications. Each milliliter of solution contains 0.01 percent of fluocinolone acetonide in 60 percent dimethyl sulfoxide with propylene glycol and citric acid.

(b) Sponsor. See No. 000033 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is used in dogs for the relief of pruritis and inflammation associated with acute and chronic otitis.

(2) It is administered at 4 to 6 drops (0.2 milliliter) twice daily into the ear canal for a maximum period of 14 days. The total dosage used should not exceed 17 milliliters. The ear canal should be cleansed by some appropriate method prior to instillation of the solution and the ear should be massaged gently following instillation.

(3) There should be careful initial evaluation and followup of infected ears. Incomplete response or exacerbation of corticosteroid-responsive lesions may be due to the presence of an infection which requires identification or antibiotic sensitivity testing, and the use of the appropriate antimicrobial agent. As with any corticosteroid, animals with a generalized infection should not be treated with this product without proper supportive antimicrobial therapy. Preparations with dimethyl sulfoxide should not be used in pregnant animals. For use by or on the order of a licensed veterinarian.

(a) Specifications. The product contains either 4 or 10 percent furazolidone in inert dispersing agent and propellant.

(b) Sponsors. (1) See No. 053501 in §510.600(c) of this chapter for use as in paragraphs (c)(1), (c)(2)(i), (c)(2)(ii), and (c)(3) of this section.

(2) See No. 017135 for use of the 4 percent product as in paragraph (c)(2)(iv) of this section.

(c) Conditions of use—(1) Amount. Hold container about 6 to 12 inches from the eye or affected area and apply only enough powder to impart a light yellow color.

(2) Indications of use—(i) Dogs. For treatment or prevention of bacterial infection of superficial wounds, abrasions, lacerations, and pyogenic dermatitis.

(ii) Horses. For treatment or prevention of bacterial infection of superficial wounds, abrasions, lacerations, and following firing (heat or electrocautery).

(iii) [Reserved]

(iv) Horses and ponies. For treatment or prevention of bacterial infection of superficial wounds, abrasions, and lacerations caused by Staphylococcus aureus, Streptococcus spp. and Proteus spp. sensitive to furazolidone.

(3) Limitations. For topical application in horses, ponies, and dogs: Clean affected area thoroughly, apply drug once or twice daily, and repeat treatment as required. Use only as recommended by a veterinarian in treatment of puncture wounds, wounds requiring surgical debridement or suturing, those of a chronic nature involving proud flesh, generalized and chronic infections of the skin, and those skin conditions associated with intense itching. If redness, irritation, or swelling persists or increases, discontinue use and consult a veterinarian. Not for use in horses intended for food.

[45 FR 49543, July 25, 1980, as amended at 50 FR 30153, July 24, 1985; 56 FR 50653, Oct. 8, 1991; 57 FR 31314, July 15, 1992; 60 FR 55659, Nov. 2, 1995; 65 FR 41588, July 6, 2000]

(a) Specifications. Each milliliter of sterile aqueous solution contains gentamicin sulfate equivalent to 3 milligrams of gentamicin.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is used in dogs and cats for the topical treatment of infections of the conjunctiva caused by susceptible bacteria.

(2) Administer 1 or 2 drops into the conjunctival sac 2 to 4 times a day.

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[41 FR 14189, Apr. 2, 1976, as amended at 52 FR 7832, Mar. 13, 1987]

(a) Specifications. Each milliliter of solution contains gentamicin sulfate equivalent to 3 milligrams (mg) gentamicin base and betamethasone valerate equivalent to 1 mg betamethasone alcohol.

(b) Sponsors. See Nos. 000061 and 054925 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amounts and indications for use—(i) For the treatment of acute and chronic otitis externa caused by bacteria sensitive to gentamicin in dogs, instill three to eight drops of solution into the ear canal twice daily for 7 to 14 days.

(ii) For the treatment of infected superficial lesions caused by bacteria sensitive to gentamicin in dogs and cats, apply a sufficient amount of the drug to cover the treatment area twice daily for 7 to 14 days.

(2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[71 FR 13542, Mar. 16, 2006]

(a) Specifications. Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin.

(b) Sponsors. See Nos. 000061 and 025463 in §510.600(c) of this chapter.

(c) Conditions of use in dogs and cats—(1) Amount. Apply approximately a 1/2-inch strip to the affected eye 2 to 4 times a day.

(2) Indications for use. For treatment of conjunctivitis caused by susceptible bacteria.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[69 FR 47363, Aug. 5, 2004]

(a) Specifications. Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin base and betamethasone valerate equivalent to 1 milligram of betamethasone.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is used or indicated for use in dogs in the treatment of acute and chronic canine otitis externa and canine infected superficial lesions caused by bacteria sensitive to gentamicin.

(2)(i) For the treatment of acute and chronic canine otitis externa the drug is administered by instillation of 3 to 8 drops into the ear canal twice daily for 7 days. The external ear and ear canal should be properly cleaned and dried before treatment. Remove foreign material, debris, crusted exudates, etc., with suitable nonirritating solutions. Excessive hair should be clipped from the treatment area of the external ear.

(ii) For the treatment of canine infected superficial lesions, the lesion and adjacent area should be properly cleaned before treatment. Excessive hair should be removed. A sufficient amount of the drug should be applied to cover the treatment area. The drug should be administered twice daily for 7 to 14 days.

(3) If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Observe patients for signs of adrenocorticoid overdosage. The antibiotic susceptibility of the pathogenic organism should be determined prior to use of this preparation. Administration of recommended doses beyond 7 days may result in delayed wound healing. Animals treated longer than 7 days should be monitored closely.

(4) For use by or on the order of a licensed veterinarian.

[47 FR 26378, June 18, 1982, as amended at 52 FR 7832, Mar. 13, 1987]

(a) Specification. Each milliliter of sterile aqueous solution contains gentamicin sulfate equivalent to 1.07 milligrams of gentamicin.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is indicated for the treatment of pink eye in cattle (infectious bovine keratoconjunctivitis) caused by Moraxella bovis.

(2) One actuation of the sprayer delivers 0.7 milliliter containing 0.75 milligram gentamicin. The sprayer should be held upright 3 to 6 inches from the affected eye, with the opening directed towards the eye, and pumped once. It is advisable to treat once a day for up to 3 days.

(3) Conditions other than bacterial infections of the bovine eye and infectious keratoconjunctivitis caused by Moraxella bovis may produce similar signs. If conditions persists or increases, discontinue use and consult veterinarian.

[48 FR 41157, Sept. 14, 1983, as amended 52 FR 7833, Mar. 13, 1987]

(a) Specifications. Each milliliter of spray contains gentamicin sulfate equivalent to 0.57 milligram (mg) gentamicin base and betamethasone valerate equivalent to 0.284 mg betamethasone.

(b) Sponsors. See Nos. 000061 and 054925 in §510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. Hold bottle upright 3 to 6 inches from the lesion and depress the sprayer head twice. Administer two spray actuations two to four times daily for 7 days.

(2) Indications for use. For the treatment of infected superficial lesions caused by bacteria sensitive to gentamicin.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[71 FR 13542, Mar. 16, 2006]

(a) Specifications. Each gram (g) of ointment contains gentamicin sulfate equivalent to 3 milligrams (mg) gentamicin base, betamethasone valerate equivalent to 1 mg betamethasone, and 10 mg clotrimazole.

(b) Sponsors. See sponsors in §510.600(c) of this chapter for uses as in paragraph (c) of this section.

(1) No. 000061 for use of 7.5- or 15-gram (g) tubes, 12.5-, 30-, or 215-g bottles.

(2) No. 054925 for use of 7.5- or 15-g tubes; 10-, 15-, 25-, or 215-g bottles.

(3) No. 059130 for use of 10-, 20-, or 215-g bottles.

(4) No. 025463 for use of 7.5- or 15-g tubes, or 215-g bottles.

(c) Conditions of use in dogs—(1) Amount. Instill ointment twice daily into the ear canal. Therapy should continue for 7 consecutive days.

(i) From 7.5- or 15-g tubes; 10-, &fnl;12.5-, 15-, 25-, or 30-g bottles: 4 drops for dogs weighing less than 30 pounds (lb) or 8 drops for dogs weighing 30 lb or more.

(ii) From 20- or 215-g bottles: 2 drops for dogs weighing less than 30 lb or 4 drops for dogs weighing 30 lb or more.

(2) Indications for use. For the treatment of acute and chronic canine otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[58 FR 38973, July 21, 1993, as amended at 63 FR 31932, June 11, 1998; 68 FR 42970, July 21, 2003; 70 FR 8291, Feb. 18, 2005; 71 FR 13542, Mar. 16, 2006; 71 FR 16481, Apr. 3, 2006; 71 FR 38261, July 6, 2006]

(a) Specifications. Each gram contains gentamicin sulfate, United States Pharmacopeia (USP) equivalent to 3 milligram (mg) gentamicin base, mometasone furoate monohydrate equivalent to 1 mg mometasone, and 10 mg clotrimazole, USP.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. For dogs weighing less than 30 pounds (lb), instill 4 drops from the 7.5-, 15-, or 30-gram (g) bottle into the ear canal (2 drops from the 215-g bottle) or, for dogs weighing 30 lb or more, instill 8 drops from the 7.5-, 15-, or 30-g bottle into the ear canal (4 drops from the 215-g bottle), once or twice daily for 7 days.

(2) Indications for use. For the treatment of otitis externa caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas spp. [including P. aeruginosa], coagulase-positive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci).

[66 FR 712, Jan. 4, 2001, as amended at 68 FR 15370, Mar. 31, 2003; 70 FR 36338, June 23, 2005]

(a) Specifications. The product is available in unit applicator tubes containing 0.4, 1.0, 2.5, or 4.0 milliliters (mL). Each mL of solution contains 100 milligrams (mg) imidacloprid and 800 micrograms (µg) ivermectin.

(b) Sponsor. See No. 000859 in §510.600(c) of this chapter.

(c) Conditions of Use in Dogs—(1) Amount. The recommended minimum dosage is 4.5 mg/pound (lb) (10 mg/kilogram (kg)) of imidacloprid and 36.4 µg/lb (80 µg/kg) of ivermectin, topically once a month.

(2) Indications for Use. For the prevention of heartworm disease caused by Dirofilaria immitis; kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis).

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[67 FR 78685, Dec. 26, 2002]

(a) Specifications. Each milliliter (mL) of solution contains 5 milligrams of ivermectin.

(b) Sponsors. See sponsors in §510.600(c) of this chapter for use as in paragraph (e) of this section.

(1) No. 050604 for use as in paragraphs (e)(1), (e)(2)(i), (e)(2)(iii), and (e)(3) of this section.

(2) Nos. 051311, 054925, 055529, 058829, 059130, and 066916 for use as in paragraphs (e)(1), (e)(2)(i), (e)(2)(ii), and (e)(3) of this section.

(c) Related tolerances. See §556.344 of this chapter.

(d) Special considerations. See §500.25 of this chapter.

(e) Conditions of use in cattle—(1) Amount. One mL per 22 pounds (0.5 milligram per kilogram) of body weight applied topically to the back of the animal.

(2) Indications for use—(i) It is used for the treatment and control of: Gastrointestinal roundworms (adults and fourth-stage larvae) Ostertagia ostertagi (including inhibited stage), Haemonchus placei, Trichostrongylus axei, T. colubriformis, Cooperia oncophora, C. punctata, C. surnabada, Oesophagostomum radiatum; (adults) Strongyloides papillosus, Trichuris spp.; lungworms (adults and fourth-stage larvae) Dictyocaulus viviparus; cattle grubs (parasitic stages) Hypoderma bovis, H. lineatum; mites Sarcoptes scabei var. bovis; lice Linognathus vituli, Haematopinus eurysternus, Damalinia bovis, Solenoptes capillatus; and horn flies Haematobia irritans.

(ii) It controls infections and prevents reinfection with O. ostertagi, O. radiatum, H. placei, T. axei, C. punctata, and C. oncophora for 14 days after treatment.

(iii) It controls infections and prevents reinfection with O. radiatum and D. viviparus for 28 days after treatment, C. punctata and T. axei for 21 days after treatment, H. placei, C. oncophora, and C. surnabada for 14 days after treatment, and D. bovis for 56 days after treatment.

(3) Limitations. Do not treat cattle within 48 days of slaughter. Because a withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product on preruminating calves. Do not use on calves to be processed for veal.

[55 FR 50551, Dec. 7, 1990, as amended at 62 FR 38908, July 21, 1997; 62 FR 63271, Nov. 28, 1997; 63 FR 44385, Aug. 19, 1998; 66 FR 13236, Mar. 5, 2001; 66 FR 63165, Dec. 5, 2001; 68 FR 3817, Jan. 27, 2003; 68 FR 4713, Jan. 30, 2003; 69 FR 501, Jan. 6, 2004; 69 FR 62181, Oct. 25, 2004; 71 FR 13542, Mar. 16, 2006]

(a) Specifications. Each tube contains 0.5 milliliter (mL) of a 0.01 percent suspension of ivermectin.

(b) Sponsor. See No. 065274 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. Administer the contents of one 0.5-mL tube topically into each external ear canal.

(2) Indications for use. For the treatment of adult ear mite (Otodectes cynotis) infestations in cats and kittens 4 weeks of age and older. Effectiveness against eggs and immature stages has not been proven.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[66 FR 7578, Jan. 24, 2001]

(a) Specifications. The drug, which is in a suitable and harmless ointment base, contains 3.5 milligrams of kanamycin activity (as the sulfate) per gram of ointment.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Conditions of use. It is indicated for use in dogs in various eye infections due to kanamycin sensitive bacteria. It is used treating conditions such as conjunctivitis, blepharitis, dacryocystitis, keratitis, and corneal ulcerations and as a prophylactic in traumatic conditions, removal of foreign bodies, and intraocular surgery. Apply a thin film to the affected eye three or four times daily or more frequently if deemed advisable. Treatment should be continued for at least 48 hours after the eye appears normal. For use only by or on the order of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 53 FR 27851, July 25, 1988; 64 FR 404, Jan. 5, 1999]

(a) Specifications. The drug, which is in an aqueous solution including suitable and harmless preservatives and buffer substances, contains 10 milligrams of kanamycin activity (as the sulfate) per milliliter of solution.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Conditions of use. It is indicated for use in dogs in various eye infections due to kanamycin sensitive bacteria. It is used in treating conditions such as conjunctivities, blepharitis, dacryocystitis, keratitis, and corneal ulcerations and as a prophylactic in traumatic conditions, removal of foreign bodies, and intraocular surgery. Instill a few drops into the affected eye every 3 hours or more frequently if deemed advisable. Administer as frequently as possible for the first 48 hours, after which the frequency of applications may be decreased. Treatment should be continued for at least 48 hours after the eye appears normal. For use only by or on the order of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 53 FR 27851, July 25, 1988; 64 FR 404, Jan. 5, 1999]

(a) Specifications. (1) Calcium amphomycin is the calcium salt of amphomycin. It conforms to the following specifications:

(i) Its potency is not less than 863 micrograms of amphomycin per milligram;

(ii) Its moisture content is not more than 10 percent; and

(iii) Its pH in a 2-percent aqueous suspension is 6.0 to 7.5.

(2) The drug is in a water-miscible ointment or cream base and each gram of ointment or cream contains: 5.0 milligrams of kanamycin activity as the sulfate, 5.0 milligrams of amphomycin activity as the calcium salt, and 10.0 milligrams of hydrocortisone acetate.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Conditions of use. (1) It is indicated for use in dogs in the following conditions associated with bacterial infections caused by organisms susceptible to one or both antibiotics: Acute otitis externa, furunculosis, folliculitis, pruritus, anal gland infections, erythema, decubital ulcer, superficial wounds, and superficial abscesses.

(2) The ointment should be applied to the affected areas of the skin at least twice daily. In severe or widespread lesions it may be desirable to apply the ointment more than twice daily. After some improvement is observed, treatment can usually be reduced to once daily. Before application, hair in the affected area should be closely clipped and the area should be thoroughly cleansed of crusts, scales, dirt, or other detritus. When treating infections of the anal gland, the drug should be introduced into the orifice of the gland and not through any fistulous tract. If no response is evident in 7 days, diagnosis and therapy should be reevaluated.

(3) For use only by or on the order of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 53 FR 12512, Apr. 15, 1988; 53 FR 27851, July 25, 1988; 64 FR 404, Jan. 5, 1999]

(a) Specifications. The drug contains 200 milligrams of levamisole per milliliter of diethylene glycol monobutyl ether (DGME) solution.

(b) Sponsor. See 000061 and 053501 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.350 of this chapter.

(d) Conditions of use. Cattle—(1) Amount. 2.5 milliliters per 110 pounds (10 milligrams of levamisole per kilogram) of body weight as a single dose topically to the back of the animal.

(2) Indications for use. Anthelmintic effective against stomach worms (Haemonchus, Trichostrongylus, Ostertagia), intestinal worms (Trichostrongylus, Cooperia, Nematodirus, Bunostomum, Oesophagostomum, Chabertia), and lungworms (Dictyocaulus).

(3) Limitations. Conditions of constant helminth exposure may require retreatment within 2 to 4 weeks after the first treatment. Cattle must not be slaughtered within 9 days following last treatment. Do not administer to dairy animals of breeding age. Do not treat animals before dipping or prior to exposure to heavy rain. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism, and before using in severely debilitated animals.

[52 FR 10887, Apr. 6, 1987, as amended at 53 FR 7504, Mar. 9, 1988; 62 FR 61626, Nov. 19, 1997; 67 FR 78355, Dec. 24, 2002]

(a) Specifications. The drug contains 1.3 percent 2-mercaptobenzothiazole in a suitable solvent.

(b) Sponsor. See 017135 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. Apply twice daily to affected area.

(2) Indications for use. For dogs as an aid in the treatment of hot spots (moist dermatitis) and as first aid for scrapes and abrasions.

(3) Limitations. Clip hair from affected area before applying. If no improvement is seen within 1 week, consult a veterinarian.

[48 FR 15618, Apr. 12, 1983, as amended at 65 FR 50913, Aug. 22, 2000; 68 FR 33381, June 4, 2003]

(a) Specifications—(1) Each gram of cream contains miconazole nitrate equivalent to 20 milligrams miconazole base.

(2) Each gram of lotion or spray contains miconazole nitrate equivalent to 1 percent miconazole base.

(b) Sponsors. See §510.600(c) of this chapter for use as in paragraph (c) of this section:

(1) No. 000061 for use of cream, lotion, and spray;

(2) Nos. 054925 and 058829 for use of lotion and spray.

(c) Conditions of use in dogs and cats—(1) Amount. Apply once daily by rubbing into or spraying a light covering on the infected site and the immediate surrounding vicinity. Continue treatment for 2 to 4 weeks until infection is completely eradicated as determined by appropriate laboratory examination.

(2) Indications for use. For topical treatment of infections caused by Microsporum canis, Microsporum gypseum, and Trichophyton mentagrophytes.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[71 FR 13542, Mar. 16, 2006]

(a) Specifications. Each tube contains 0.25 milliliter of a 0.1 percent solution of milbemycin oxime.

(b) Sponsor. See No. 058198 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. One tube administered topically into each external ear canal.

(2) Indications for use. For the treatment of ear mite (Otodectes cynotis) infestations in cats and kittens 4 weeks of age and older. Effectiveness is maintained throughout the life cycle of the ear mite.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[65 FR 13905, Mar. 15, 2000, as amended at 66 FR 13849, Mar. 8, 2001]

(a) Specifications. Each milliliter contains 5 milligrams of moxidectin (0.5 percent solution).

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Related tolerances. See §556.426 of this chapter.

(d) Special considerations. See §500.25 of this chapter.

(e) Conditions of use–(1) Amount. 0.5 milligrams moxidectin per kilogram (2.2 pounds) of body weight.

(2) Indications for use. Beef and dairy cattle: For treatment and control of internal and external parasites: gastrointestinal roundworms (Ostertagia ostertagi (adult and L4, including inhibited larvae), Haemonchus placei (adult and L4), Trichostrongylus axei (adult and L4), T. colubriformis (adult and L4), Cooperia oncophora (adult and L4), C. pectinata (adult), C. punctata (adult and L4), C. spatulata (adult), C. surnabada (adult and L4), Bunostomum phlebotomum (adult), Oesophagostomum radiatum (adult and L4), Nematodirus helvetianus (adult and L4)); lungworms (Dictyocaulus viviparus, adult and L4); cattle grubs (Hypoderma bovis, H. lineatum); mites (Chorioptes bovis, Psoroptes ovis (P. communis var. bovis)); lice (Linognathus vituli, Haematopinus eurysternus, Solenopotes capillatus, Bovicola(Damalinia) bovis); and horn flies (Haematobia irritans). To control infections and to protect from reinfection with H. placei for 14 days after treatment, O. radiatum and O. ostertagi for 28 days after treatment, and D. viviparus for 42 days after treatment.

(3) Limitations. A withdrawal period has not been established for this product on preruminating calves. Do not use on calves to be processed for veal.

[63 FR 14036, Mar. 24, 1998, as amended at 65 FR 36617, June 9, 2000; 66 FR 46370, Sept. 5, 2001]

(a) Specifications. Each gram contains 20 milligrams of mupirocin.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Dogs:

(i) Indications for use. Topical treatment of bacterial infections of the skin, including superficial pyoderma, caused by susceptible strains of Staphylococcus aureus and Staphylococcus intermedius.

(ii) Limitations. Apply twice daily. Treatment should not exceed 30 days. Because of potential hazard of nephrotoxicity due to polyethylene glycol content, care should be exercised in treating deep lesions. Safety of use in pregnant or breeding animals has not been determined. Not for ophthalmic use. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(2) [Reserved]

[53 FR 39085, Oct. 5, 1988, as amended at 56 FR 50653, Oct. 8, 1991; 60 FR 55659, Nov. 2, 1995]

(a) Specifications. Each gram of the ointment contains 5 milligrams of neomycin sulfate equivalent in activity to 3.5 milligrams of neomycin base.

(b) Sponsor. See No. 017030 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is intended for use in dogs and cats for the treatment of superficial ocular bacterial infections limited to the conjunctival or the anterior segment of the eye.

(2) The drug is applied four times each day.

(3) The drug is applied by inserting the tip of the tube beneath the lower lid and by expressing a small quantity of ointment into the conjunctival sac. The tip of the tube should not come in contact with the eye surface.

(4) Severe infections should be supplemented by systemic therapy.

(5) Prolonged administration of the drug may permit overgrowth of organisms that are not susceptible to neomycin. If new infections due to bacteria or fungi appear during therapy, appropriate measures should be taken.

(6) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 44 FR 49666, Aug. 24, 1979]

(a) Specifications. The product contains 5 milligrams of neomycin sulfate, equivalent to 3.5 milligrams of neomycin base, 1 milligram of isoflupredone acetate, 5 milligrams of tetracaine hydrochloride and .2 milligram of myristyl-gamma-picolinium chloride in each gram of the product in a special adherent powder base.

(b) Sponsor. See No. 000009 in §510.600(c) of this chapter.

(c) Conditions of use. (1) It is used in horses, dogs, and cats in the treatment or adjunctive therapy of certain ear and skin conditions when such conditions are caused by or associated with neomycin-susceptible organisms and/or allergy. In addition the product is indicated as superficial dressing applied to minor cuts, wounds, lacerations, abrasions, and for postsurgical application where reduction of pain and inflammatory response is deemed desirable. The product may be used as a dusting powder following amputation of tails, claws, and dew-claws and following ear trimming, castrating, and such surgical procedures as ovariohysterectomies. The product may also be used in the treatment of acute otitis externa in dogs, acute moist dermatitis and interdigital dermatitis in dogs.

(2) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 43 FR 18172, Apr. 28, 1978]

(a) Specifications. The drug contains 5 milligrams of neomycin sulfate (equivalent to 3.5 milligrams of neomycin base), 1 milligram of isoflupredone acetate, and 5 milligrams of tetracaine hydrochloride in each gram of ointment.

(b) Sponsor. See No. 000009 in §510.600(c) of this chapter.

(c) Conditions of use. (1) It is used in treating such conditions as acute otitis externa in dogs and to a lesser degree, chronic otitis externa in dogs. It also is effective in treating anal gland infections and moist dermatitis in the dog and is a useful dressing for minor cuts, lacerations, abrasions, and post-surgical therapy in the horse, cat, and dog. It may also be used following amputation of dewclaws, tails and claws, following ear trimming and castrating operations.

(2) In treatment of otitis externa and other inflammatory conditions of the external ear canal, a quantity of ointment sufficient to fill the external ear canal may be applied one to three times daily. When used on the skin or mucous membranes, the affected area should be cleansed, and a small amount of the ointment applied and spread or rubbed in gently. The involved area may be treated one to three times a day and these daily applications continued in accordance with the clinical response.

(3) Tetracaine and neomycin have the potential to sensitize. Care should be taken to observe animals being treated for evidence of hypersensitivity or allergy to the drug. If such signs are noted, therapy with the drug should be stopped. Treatment should be limited to the period when local anesthesia is essential to control self-inflicted trauma.

(4) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 43 FR 18172, Apr. 28, 1978]

(a) Specifications. The product contains 5 milligrams of neomycin sulfate, equivalent to 3.5 milligrams of neomycin base, 5 milligrams of hydrocortisone acetate, and 5 milligrams of tetracaine hydrochloride in each gram of ointment.

(b) Sponsor. See No. 000009 in §510.600(c) of this chapter.

(c) Conditions of use. (1) It is indicated for treating acute otitis externa and, to a lesser degree, chronic otitis externa in dogs and cats. In treatment of ear canker and other inflammatory conditions of the external ear canal, a quantity of ointment sufficient to fill the external ear canal may be applied one to three times daily.¹

(2) Tetracaine and neomycin have the potential to sensitize. Care should be taken to observe animals being treated for evidence of hypersensitivity or allergy to the product. If such signs are noted, therapy with the product should be stopped. Incomplete response or exacerbation of corticosteroid responsive lesions may be due to the presence of nonsusceptible organisms or to prolonged use of antibiotic-containing preparations resulting in overgrowth of nonsusceptible organisms, particularly Monilia.¹

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.¹

[40 FR 13873, Mar. 27, 1975, as amended at 49 FR 21922, May 24, 1984]

(a) Specifications. Each milliliter of the ophthalmic preparation contains 5.0 milligrams neomycin sulfate (3.5 milligrams neomycin base), and 10,000 Units of polymyxin B sulfate.

(b) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is recommended for the treatment of bacterial infections associated with topical ophthalmological conditions such as corneal injuries, superficial keratitis, conjunctivitis, keratocon- junctivities, and blepharitis in the dog.

(2) The recommended dosage is 1 to 2 drops per eye every 6 hours.

(3) In treating ophthalmological conditions associated with bacterial infections the drug is contraindicated in those cases in which microorganisms are nonsusceptible to the antibiotics incorporated in the drug.

(4) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 61 FR 5507, Feb. 13, 1996]

(a) Specifications. The product contains 5 milligrams of neomycin sulfate equivalent to 3.5 milligrams of neomycin base, 2.5 milligrams of prednisolone acetate, and 5 milligrams of tetracaine hydrochloride in each milliliter of sterile suspension.

(b) Sponsor. See No. 000009 in §510.600(c) of this chapter.

(c) Conditions of use. (1) It is useful in treating such conditions as acute otitis externa and, to a lesser degree, chronic otitis externa in dogs and cats. It is indicated as treatment or adjunctive therapy of certain ear conditions in dogs and cats caused by or associated with neomycin-susceptible organisms and/or allergy. In otitis externa, 2 to 6 drops may be placed in the external ear canal two or three times daily.¹

(2) Incomplete response or exacerbation of corticosteroid responsive lesions may be due to the presence of nonsusceptible organisms or to prolonged use of antibiotic-containing preparations resulting in overgrowth of nonsusceptible organisms, particularly Monilia. Thus, if improvement is not noted within 2 or 3 days, or if redness, irritation, or swelling persists or increases, the diagnosis should be redetermined and appropriate therapeutic measures initiated. Tetracaine and neomycin have the potential to sensitize. Care should be taken to observe animals being treated for evidence of hypersensitivity or allergy. If such signs are noted, therapy should be stopped.¹

(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.¹

(a) Specifications. Each cubic centimeter of neomycin sulfate-thiabendazole-dexamethasone solution contains: 40 milligrams of thiabendazole, 3.2 milligrams of neomycin (from neomycin sulfate), and 1 milligram of dexamethasone.

(b) Sponsor. See No. 050604 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is recommended for use as an aid in the treatment of bacterial, mycotic, and inflammatory dermatoses and otitis externa in dogs and cats.

(2) In treating dermatoses affecting areas other than the ear, the surface of the lesions should be well moistened (two to four drops per square inch) twice daily. In treating otitis externa, five to 15 drops of the drug should be instilled in the ear twice daily. The drug is limited to 7 days maximum duration of administration.

(3) For use only by or on order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 62 FR 63271, Nov. 28, 1997]

(a) Specifications. Each milliliter of suspension contains 25 milligrams of neomycin sulfate equivalent to 17.5 milligrams of neomycin, 10,000 international units of penicillin G procaine, 5,000 international units of polymyxin B sulfate, 2 milligrams of hydrocortisone acetate, and 1.25 milligrams of hydrocortisone sodium succinate.

(b) Sponsor. See 000009 in §510.600(c) of this chapter.

(c) Special considerations. The labeling shall state: This medication contains penicillin. Allergic reactions in humans are known to occur from topical exposure to penicillin.

(d) Conditions of use—dogs—(1) Amount. Rub a small amount into the involved area 1 to 3 times a day. After definite improvement, it may be applied once a day or every other day.

(2) Indications for use. Treatment of summer eczema, atopic dermatitis, interdigital eczema, and otitis externa caused by bacteria susceptible to neomycin, penicillin, and polymyxin B.

(3) Limitations. For use in dogs only. Shake drug thoroughly and clean lesion before using. If redness, irritation, or swelling persists or increases, discontinue use and reevaluate diagnosis. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[59 FR 5105, Feb. 3, 1994]

(a) Specifications. The drug contains 5 milligrams of neomycin sulfate, equivalent to 3.5 milligrams of neomycin base, and 5 milligrams of hydrocortisone acetate in each gram of ointment.¹

(b) Sponsor. No. 000009 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. Apply three or four times daily into the conjunctival sac. With improvement, frequency may be reduced to two or three times daily. For treatment of ear canker and other inflammatory conditions of the external ear canal, fill external ear canal one to three times daily.¹

(2) Indications for use. For treating infections, allergic, and traumatic keratitis, conjunctivitis, acute otitis externa and, to a lesser degree, chronic otitis externa in dogs and cats.¹

(3) Limitations. All topical ophthalmic preparations containing corticosteroids, with or without an antimicrobial agent, are contraindicated in the initial treatment of corneal ulcers. They should not be used until infection is under control and corneal regeneration is well underway. Incomplete response or exacerbation of corticosteroid responsive lesions may be due to the presence of nonsusceptible organisms or to prolonged use on antibiotic-containing preparations resulting in overgrowth of nonsusceptible organisms, particularly Monilia. Federal law restricts this drug to use by or on the order of a licensed veterinarian.¹

[43 FR 40456, Sept. 12, 1978]

(a) Specifications. Each milliliter of suspension contains 5 milligrams neomycin sulfate (equivalent to 3.5 milligrams neomycin base), 2 milligrams prednisolone, 5 milligrams tetracaine, and 0.25 milliliter squalane.

(b) Sponsor. See 017030 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. 2 to 3 applications daily or as needed.

(2) Indications for use. Indicated for use in dogs and cats for treating acute otitis externa and as adjunctive therapy in management of chronic otitis externa. The product may also be used for treating moist dermatitis in dogs.

(3) Limitations. Tetracaine and neomycin have the potential to sensitize. If signs of irritation or sensitivity develop, discontinue use. Prolonged use of this product may result in overgrowth of nonsusceptible organisms. If new infections due to bacteria or fungi appear during therapy, appropriate measures should be taken. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[48 FR 5265, Feb. 4, 1983; 48 FR 8055, Feb. 25, 1983]

(a) Specifications. The drug contains 0.2 percent nitrofurazone in a water-soluble base.

(b) Sponsors. See sponsors in §510.600(c) of this chapter.

(1) See Nos. 000010, 000069, 050749, 054925, 058005, and 061623 for use on dogs, cats, or horses.

(2) See No. 017135 for use on dogs and horses.

(c) [Reserved]

(d) Conditions of use—(1) Amount. Apply directly on the lesion with a spatula or first place on a piece of gauze. The preparation should remain on the lesion for at least 24 hours. Use of a bandage is optional.

(2) Indications for use. For prevention or treatment of surface bacterial infections of wounds, burns, and cutaneous ulcers of dogs, cats, or horses.

(3) Limitations. For use only on dogs, cats, and horses (not for food use). In case of deep or puncture wounds or serious burns, use only as recommended by veterinarian. If redness, irritation, or swelling persists or increases, discontinue use; consult veterinarian.

[46 FR 43402, June 27, 1980, as amended at 49 FR 6476, Feb. 22, 1984; 50 FR 49373, Dec. 2, 1985; 52 FR 18691, May 19, 1987; 53 FR 32610, Aug. 26, 1988; 53 FR 40728, Oct. 18, 1988; 54 FR 29544, July 13, 1989; 54 FR 37097, Sept. 7, 1989; 55 FR 8462, Mar. 8, 1990; 55 FR 20455, May 17, 1990; 56 FR 37473, Aug. 7, 1991; 56 FR 50653, Oct. 8, 1991; 59 FR 33197, June 28, 1994; 60 FR 55659, Nov. 2, 1995; 62 FR 35077, June 30, 1997; 66 FR 14074, Mar. 9, 2001; 68 FR 4915, Jan. 31, 2003; 68 FR 36913, June 20, 2003; 69 FR 47362, Aug. 5, 2004; 70 FR 50183, Aug. 26, 2005; 71 FR 13542, Mar. 16, 2006]

(a) Specifications. The drug contains 0.2 percent nitrofurazone in a water-soluble base.

(b) Sponsor. See Nos. 000010, 000069, and 050749 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Amount. Apply several times daily to the lesion or affected area from the plastic squeeze bottle.

(2) Indications for use. For prevention or treatment of surface bacterial infections of wounds, burns, skin ulcers, and abscesses after incision.¹

(3) Limitations. In case of deep or puncture wounds or serious burns, use only as recommended by veterinarian. If redness, irritation, or swelling persists or increases, discontinue use; consult veterinarian. For use only on dogs, cats, and horses (not for food use).¹

[45 FR 43402, June 27, 1980, as amended at 47 FR 43368, Oct. 1, 1982; 48 FR 28984, June 24, 1983; 53 FR 40728, Oct. 18, 1988; 54 FR 30542, July 21, 1989; 56 FR 50653, Oct. 8, 1991; 59 FR 33197, June 28, 1994; 60 FR 55659, Nov. 2, 1995; 62 FR 35077, June 30, 1997]

(a) Specifications. The drug contains 0.2 percent nitrofurazone and 0.5 percent butacaine sulfate in a water-soluble base.

(b) Sponsor. See No. 054925 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Indications for use. For prevention or treatment of surface bacterial infections of ears, wounds, burns, and cutaneous ulcers of dogs, cats, and horses.¹

(2) Limitations. Apply directly on the lesion with a spatula or first place on a piece of gauze. Use of a bandage is optional. The preparation should remain on the lesion for at least 24 hours. The dressing may be changed several times daily or left on the lesion for a longer period. For use only on dogs, cats, and horses (not for food use). In case of deep or puncture wounds or serious burns, use only as recommended by a veterinarian. If redness, irritation, or swelling persists or increases, discontinue use; consult veterinarian.¹

[49 FR 9417, Mar. 13, 1984, as amended at 71 FR 13542, Mar. 16, 2006]

(a) Specifications. Each milliliter of petrolatum base or each gram of vanishing cream base ointment contains: 100,000 units of nystatin; neomycin sulfate equivalent to 2.5 milligrams of neomycin base; 2,500 units of thiostrepton; and 1.0 milligram of triamcinolone acetonide.

(b) Sponsors. For petrolatum base ointments see 000069, 000856, 025463, 053501, and 054925 in §510.600(c) of this chapter. For vanishing cream base ointments see Nos. 025463, 053501, and 054925.

(c) Conditions of use—(1) Amount. (i) For topical dermatological use: Clean affected areas and remove any encrusted discharge or exudate, and apply sparingly either ointment in a thin film.

(ii) For otic use: Clean ear canal of impacted cerumen, remove any foreign bodies such as grass awns and ticks, and instill three to five drops of petrolatum base ointment. Preliminary use of a local anesthetic may be advisable.

(iii) For infected anal glands and cystic areas: Drain gland or cyst and fill with petrolatum base ointment.

(2) Indications for use. (i) Topically: Use either ointment in dogs and cats for anti-inflammatory, antipruritic, antifungal, and antibacterial treatment of superficial bacterial infections, and for dermatologic disorders characterized by inflammation and dry or exudative dermatitis, particularly associated with bacterial or candidal (Candida albicans) infections.

(ii) Otitis, cysts, and anal gland infections: Use petrolatum base ointment in dogs and cats for the treatment of acute and chronic otitis and interdigital cysts, and in dogs for anal gland infections.

(3) Limitations. For mild inflammations, use once daily to once a week. For severe conditions, apply initially two to three times daily, decreasing frequency as improvement occurs. Not intended for treatment of deep abscesses or deep-seated infections. Not for ophthalmic use. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 43 FR 29770, July 11, 1978; 50 FR 41490, Oct. 11, 1985; 53 FR 39257, Oct. 6, 1988; 54 FR 5431, Feb. 3, 1989; 54 FR 48090, Nov. 21, 1989; 56 FR 50653, Oct. 8, 1991; 60 FR 55660, Nov. 2, 1995; 61 FR 63712, Dec. 2, 1996; 64 FR 42831, Aug. 6, 1999; 67 FR 67521, Nov. 6, 2002; 68 FR 55201, Sept. 23, 2003; 70 FR 50183, Aug. 26, 2005; 71 FR 13542, Mar. 16, 2006]

(a) Specifications. Each cubic centimeter of ointment contains: 100,000 units of nystatin, neomycin sulfate equivalent to 2.5 milligrams of neomycin base, 2,500 units of thiostrepton, and 1.0 milligram of triamcinolone acetonide.

(b) Sponsor. See No. 053501 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is recommended for ophthalmic use as an anti-inflammatory, antipruritic, antifungal (Candida albicans), and antibacterial ointment for local therapy in keratitis and conjunctivitis in cats and dogs and for infectious kerato-conjunctivitis (pink eye) in cattle.

(2) It is to be administered as follows:

(i) For conjunctivitis and keratitis: Apply one drop of ointment to the affected eye(s) two or three times daily. Treatment may be continued for up to 2 weeks if necessary.

(ii) For bovine infectious kerato-conjunctivitis: Apply small line of ointment to the affected eye(s) once daily. Treatment may be continued for up to 2 weeks if necessary.

(iii) Frequency of administration is dependent on the severity of the condition. For mild inflammations, applications may range from once daily to once a week; for severe conditions the drug may be applied as often as two to three times daily. Frequency of treatment may be decreased as improvement occurs.

(3) For use only by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 50 FR 41490, Oct. 11, 1985]

(a) Specifications. Each 3-ounce unit of oxytetracycline hydrochloride and hydrocortisone spray contains 300 milligrams of oxytetracycline hydrochloride and 100 milligrams of hydrocortisone with an inert freon propellant such that a 1-second spray treatment will deliver approximately 2.5 milligrams of oxytetracycline hydrochloride and 0.8 milligram of hydrocortisone.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is indicated for relief of discomfort and continued treatment of many allergic, infectious, and traumatic skin conditions. The indications include prevention of bacterial infections in superficial wounds, cuts, and abrasions, treatment of allergic dermatoses, including urticaria, eczemas, insect bites, and cutaneous drug reactions, infections associated with minor burns and wounds, and nonspecific pruritus in dogs and cats.

(2) A small quantity should be sprayed on the affected surface by holding the container about 6 inches from the area to be treated and pressing the nozzle for 1 or 2 seconds. Only sufficient spray to coat the skin thinly is necessary. The application of small amounts at frequent intervals will give best results. Before treating animals with long or matted hair, it may be necessary to clip the affected area or spread the hairs to allow the medication to contact the skin surface. Relief may be noted following the first or second treatment; however, treatment should not be discontinued too soon after the initial favorable response has been obtained.

(3) Keep away from eyes or other mucous membranes; avoid inhaling; use with adequate ventilation; in case of deep or puncture wounds or serious burns, consult a veterinarian.

(a) Specifications. Each gram of the ointment contains oxytetracycline hydrochloride equivalent to 5 milligrams of oxytetracycline and 10,000 units of polymyxin B sulfate.

(b) Sponsor. See No. 000069 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is used for the prophylaxis and local treatment of superficial ocular infections due to oxytetracycline- and polymyxin-sensitive organisms. These infections include the following: Ocular infections due to streptococci, rickettsiae, E. coli, and A. aerogenes (such as conjunctivitis, keratitis, pinkeye, corneal ulcer, and blepharitis in dogs, cats, cattle, sheep, and horses); ocular infections due to secondary bacterial complications associated with distemper in dogs; and ocular infections due to bacterial inflammatory conditions which may occur secondary to other infectious diseases in dogs, cats, cattle, sheep, and horses.

(2) It is administered topically to the eye two to four times daily.

(3) Allergic reactions may occasionally occur. Treatment should be discontinued if reactions are severe. If new infections due to nonsensitive bacteria or fungi appear during therapy, appropriate measures should be taken.

(a) Specifications. The emulsifiable liquid contains 11.6 percent N-(mercaptomethyl) phthalimide S-(O,O- dimethyl phosphorodithioate).

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use—(1) Methods of application. Methods of application to control the following conditions on beef cattle:

(i) Dip vat procedure. (a) Prior to charging vat, empty old contents and thoroughly clean the vat. Dip vats should be calibrated to maintain an accurate dilution. Add water, then drug to the vat according to the dilution rate indicated in the table. Add super phosphate at a rate of 100 pounds per 1,000 gallons of vat solution. Super phosphate is added to control the pH of the solution and ensure vat stability. Super phosphate is usually available at most fertilizer dealers as 0–45–0 or 0–46–0. Stir the dip thoroughly, preferably with a compressed air device; however, any form of thorough mixing is adequate. Re-stir vat contents prior to each use. During the dipping operation, each time the dip's volume is reduced by 1/8 to 1/4 of its initial volume, replenish with water and add the drug at a rate of 1 gallon for each 50 or 200 gallons water added—depending on dilution rate 1:60 or 1:240. Also add super phosphate as necessary to maintain pH between 4.5 and 6.5. Stir well and resume dipping. Repeat replenishment process as necessary. For evaportion, add additional water accordingly. For added water due to rainfall, merely replenish dip with the product according to directions. If overflow occurs, either analyze for drug concentration and adjust accordingly or dispose of vat contents and recharge. Check pH after each addition of water or super phosphate to assure proper pH controls.

(b) Dip maintenance. (1) With use of dip vat tester, dipping may continue as long as the drug concentration is maintained between 0.15 and 0.25 percent, and the dip is not too foul for satisfactory use as indicated by foul odor or excessive darkening (i.e., color changes from beige to very dark brown).

(2) Without use of dip vat tester, vat should be emptied, cleaned, and recharged each time one of the following occurs: When the dip has been charged for 120 days; when the dip becomes too foul for satisfactory use, within the 120-day limit; if the number of animals dipped equals twice the number of gallons of the initial dip volume, within the 120-day limit.

(ii) Spray method. To prepare the spray, mix drug with water according to table and stir thoroughly. Apply the fresh mixture as a high-pressure spray, taking care to wet the skin, not just the hair. Apply to the point of “runoff,” about 1 gallon of diluted spray per adult animal. Lesser amounts will permit runoff for younger animals.

(iii) Pour-on method. Dilute the drug with water according to table by slowly adding water to the product while stirring. Apply 1 ounce of the diluted mixture per 100 pounds of body weight (to a maximum of 8 ounces per head) down the center line of the back.

(2) Timing of applications for cattle grub control. For optimum cattle grub control, it is important to treat as soon as possible after the heel fly season, before the grub larvae reach the gullet or spinal canal, as the rapid kill of large numbers of larvae in these tissues may cause toxic side effects, such as bloat, salivation, staggering, and paralysis.

(3) Treatment regimens. (i) Control of scabies mites requires two treatments, 10 to 14 days apart.

(ii) Control of Lone Star Ticks and hornflies requires two treatments, 7 days apart.

(4) Warnings. The drug is a cholinesterase inhibitor. Do not use this drug on animals simultaneously or within a few days before or after treatment with or exposure to cholinesterase-inhibiting drugs, pesticides, or chemicals. Do not apply within 21 days of slaughter. For use on beef cattle only. Do not treat sick, convalescent, or stressed cattle, or calves less than 3 months old except in Federal or State eradication programs where immediate treatment of all animals in an infested herd is mandatory. Be sure free access to drinking water is available to cattle prior to dipping. Do not dip excessively thirsty animals. Do not dip animals when overheated. Repeat treatment as necessary but not more often than every 7 to 10 days. Treatment for lice, ticks, hornflies, and scabies mites may be made any time of the year except when cattle grub larvae are in the gullet or spinal canal. Treatment for lice, ticks, and scabies mites may be made any time 7 to 10 days following treatment for grubs. Do not treat grubs when the grub larvae are in the gullet or spinal canal. Do not get in eyes, on skin, or on clothing. Do not breathe spray mist. Wear rubber gloves, goggles, and protective clothing. In case of skin contact, wash immediately with soap and water; for eyes, flush with water. Wash all contaminated clothing with soap and hot water before re-use.

(d) Related tolerances. See 40 CFR 180.261.

[40 FR 13873, Mar. 27, 1975, as amended at 46 FR 27914, May 22, 1981; 48 FR 39607, Sept. 1, 1983; 54 FR 51021, Dec. 12, 1989; 61 FR 8873, Mar. 6, 1996; 62 FR 61626, Nov. 19, 1997; 63 FR 5255, Feb. 2, 1998]

(a) Specifications. Prednisolone-neomycin sulfate ophthalmic ointment contains 2 milligrams prednisolone and 5 milligrams neomycin sulfate (equivalent to 3.5 milligrams neomycin base) in each gram of ointment.

(b) Sponsor. See No. 017030 in §510.600(c) of this chapter.

(c) Conditions of use. The drug is recommended for use in superficial ocular inflammations or infections limited to the conjunctiva or the anterior segment of the eye of cats and dogs, such as those associated with allergic reactions or gross irritants. A small quantity of the ointment should be expressed into the conjunctival sac four times a day for 7 days. After 7 days, if clinical improvement is not noted, reevaluation of the diagnosis should be considered. All topical ophthalmic preparations containing corticosteroids with or without an antimicrobial agent are contraindicated in the initial treatment of corneal ulcers. They should not be used until the infection is under control and corneal regeneration is well underway. For use only by or on the order of a licensed veterinarian.

(a) Specifications. Prednisolone acetate-neomycin sulfate sterile suspension contains 2.5 milligrams of prednisolone acetate and 5 milligrams of neomycin sulfate (equivalent to 3.5 milligrams of neomycin base) in each milliliter of sterile suspension.

(b) Sponsor. See No. 000009 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is indicated for treating infectious, allergic and traumatic keratitis and conjunctivitis, acute otitis externa, and chronic otitis externa in dogs and cats.

(2) For beginning treatment of acute ocular inflammations 1 or 2 drops may be placed in the conjunctival sac 3 to 6 times during a 24 hour period. When improvement occurs, the dosage may be reduced to 1 drop 2 to 4 times daily. In otitis externa, 2 to 6 drops may be placed in the external ear canal 2 or 3 times daily.

(3) All topical ophthalmic preparations containing corticosteroids with or without an anti-microbial agent are contraindicated in the initial treatment of corneal ulcers. They should not be used until infection is under control and corneal regeneration is well underway.

(4) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

(a) Specifications. Prednisolone sodium phosphate-neomycin sulfate ophthalmic ointment contains prednisolone sodium phosphate equivalent to 2.5 milligrams prednisolone 21-phosphate and 5 milligrams neomycin sulfate (equivalent to 3.5 milligrams neomycin base) in each gram of ointment.

(b) Sponsor. See No. 050604 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is recommended for use in superficial ocular inflammations or infections limited to the conjunctiva or the anterior segment of the eye of cats and dogs, such as those associated with allergic reactions or gross irritants.¹

(2) A small quantity of the ointment should be expressed into the conjunctival sac 4 times a day (at intervals of 1 to 8 hours) for a few days until there is a favorable response, then the frequency of application may be reduced to twice daily as long as the condition remains under control. Treatment may require from a few days to several weeks.¹

(3) All topical ophthalmic preparations containing corticosteroids with or without an antimicrobial agent are contraindicated in the initial treatment of corneal ulcers. They should not be used until the infection is under control and corneal regeneration is well underway.¹

(4) For use only by or on the order of a licensed veterinarian.¹

[40 FR 13873, Mar. 27, 1975, as amended at 62 FR 63271, Nov. 28, 1997]

(a) Specifications. The drug is an aqueous solution containing 0.5 percent proparacaine hydrochloride, 2.45 percent glycerin as a stabilizer, and 0.2 percent chlorobutanol (choral derivative) and 1:10,000 benzalkonium chloride as preservatives.

(b) Sponsor. See No. 053501 in §510.600(c) of this chapter.

(c) Special considerations. The longterm toxicity of proparacaine is unknown. Prolonged use may possibly delay wound healing.

(d) Conditions of use. (1) The drug is indicated for use as a topical ophthalmic anesthetic in animals. It is used as an anesthetic in cauterization of corneal ulcers, removal of foreign bodies and sutures from the cornea, and measurement of intraocular pressure (tonometry) when glaucoma is suspected. Local applications may also be used as an aid in the removal of foreign bodies from the nose and ear canal, as an accessory in the examination and treatment of painful otitis, in minor surgery, and prior to catheterization.

(2) It is administered as follows:

(i) For removal of sutures: Instill one to two drops 2 or 3 minutes before removal of stitches.

(ii) For removal of foreign bodies from eye, ear, and nose: For ophthalmic use, instill three to five drops in the eye prior to examination; for otic use, instill five to 10 drops in the ear; for nasal use, instill five to 10 drops in each nostril every 3 minutes for three doses.

(iii) For tonometry: Instill one to two drops immediately before measurement.

(iv) As an aid in treatment of otitis: Instill two drops into the ear every 5 minutes for three doses.

(v) For minor surgery: Instill one or more drops as required.

(vi) For catheterization: Instill two to three drops with a blunt 20-gauge needle immediately before inserting catheter.

(3) For use only by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 50 FR 41490, Oct. 11, 1985]

(a) Specifications. Each milliliter contains 60 or 120 milligrams of selamectin.

(b) Sponsor. See 000069 in §510.600(c) of this chapter.

(c) [Reserved]

(d) Conditions of use—(1) Amount. 2.7 milligrams of selamectin, topically, per pound (6 milligrams per kilogram) of body weight.

(2) Indications for use. Kills adult fleas and prevents flea eggs from hatching for 1 month, and it is indicated for the prevention and control of flea infestations (Ctenocephalides felis), prevention of heartworm disease caused by Dirofilaria immitis, and treatment and control of ear mite (Otodectes cynotis) infestations in dogs and cats. Treatment and control of sarcoptic mange (Sarcoptes scabiei) and control of tick (Dermacentor variabilis) infestations in dogs. Treatment and control of intestinal hookworm (Ancylostoma tubaeforme) and roundworm (Toxocara cati) infections in cats. For dogs and cats 6 weeks of age and older.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[64 FR 37401, July 12, 1999, as amended at 64 FR 48707, Sept. 8, 1999; 65 FR 45282, July 21, 2000]

(a) Specifications. The product contains 0.9-percent weight in weight (w/w) selenium disulfide (1-percent weight in volume (w/v)).

(b) Sponsors. See Nos. 000061, 017135, and 050604 in §510.600(c) of this chapter.

(c) Conditions of use on dogs—(1) Indications for use. For use as a cleansing shampoo and as an agent for removing skin debris associated with dry eczema, seborrhea, and nonspecific dermatoses.

(2) Amount. One to 2 ounces per application.

(3) Limitations. Use carefully around scrotum and eyes, covering scrotum with petrolatum. Allow the shampoo to remain for 5 to 15 minutes before thorough rinsing. Repeat treatment once or twice a week. If conditions persist or if rash or irritation develops, discontinue use and consult a veterinarian.

[47 FR 53351, Nov. 26, 1982, as amended at 48 FR 32762, July 19, 1983; 54 FR 36962, Sept. 6, 1989; 56 FR 9623, Mar. 7, 1991; 58 FR 41025, Aug. 2, 1993; 63 FR 26981, May 15, 1998; 70 FR 50183, Aug. 26, 2005]

(a) Specifications. The drug contains 1 percent tolnaftate (2-naphthyl-N-methyl-N-(3-tolyl) thionocarbamate) in an anhydrous cream base.

(b) Sponsor. See No. 000061 in §510.600(c) of this chapter.

(c) Conditions of use. (1) The drug is indicated for treatment of ringworm lesions due to Microsporum canis and Microsporum gypseum in dogs and cats.

(2) A small amount of the cream is applied to the affected areas once or twice a day for 2 to 4 weeks. The areas to be treated are first cleared of exudate and the hair clipped if the areas are not already denuded. The cream is massaged into each lesion and immediate surrounding area until the cream is no longer visible.

(3) If no response is seen after 2 weeks of treatment with the drug the diagnosis should be reviewed.

(4) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[43 FR 29289, July 7, 1978, as amended at 52 FR 7833, Mar. 13, 1987]

(a) Specifications. The vanishing cream contains 0.1 percent triamcinolone acetonide.

(b) Sponsor. See Nos. 053501 and 054925 in §510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. Rub into affected areas two to four times daily for 4 to 10 days.

(2) Indications for use. As an anti-inflammatory, antipruritic, and antiallergic agent for topical treatment of allergic dermatitis and summer eczema.

(3) Limitations. Federal law restricts this drug to use only by or on the order of a licensed veterinarian.

[71 FR 13542, Mar. 16, 2006]

(a) Specifications. Each milliliter of solution contains 0.15 milligrams triamcinolone acetonide.

(b) Sponsor. See No. 067292 in §510.600(c) of this chapter.

(c) Conditions of use in dogs—(1) Amount. Apply sufficient pump sprays to uniformly and thoroughly wet the affected areas while avoiding run off of excess product. Administer twice daily for 7 days, then once daily for 7 days, then every other day for an additional 14 days (28 days total).

(2) Indications for use. For the control of pruritus associated with allergic dermatitis.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[68 FR 4916, Jan. 31, 2003]

(a)(1) Specifications. The drug is a liquid for direct application or an aerosol preparation formulated so that each gram delivered to the wound site contains 0.12 milligram of crystalline trypsin, 87.0 milligrams of Peru balsam, and 788.0 milligrams of castor oil.

(2) Sponsor. See No. 062794 in §510.600(c) of this chapter.

(b)(1) Specifications. The drug is a liquid for direct application or an aerosol preparation formulated so that each gram delivered to the wound site contains 0.1 milligram of crystalline trypsin, 72.5 milligrams of Peru balsam, and 800 milligrams of castor oil.

(2) Sponsor. See No. 017135 in §510.600(c) of this chapter.

(c) Conditions of use. The drug is used as an aid in the treatment of external wounds and assists healing by facilitating the removal of necrotic tissue, exudate and organic debris.

[40 FR 13873, Mar. 27, 1975, as amended at 41 FR 56307, Dec. 28, 1976; 50 FR 9800, Mar. 12, 1985; 54 FR 25565, June 16, 1989; 56 FR 37474, Aug. 7, 1991; 66 FR 46369, Sept. 5, 2001]

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