21 C.F.R. § 524.1484b Neomycin sulfate, isoflupredone acetate, tetracaine hydrochloride, and myristyl-gamma-picolinium chloride, topical powder.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
§ 524.1484b Neomycin sulfate, isoflupredone acetate, tetracaine hydrochloride, and myristyl-gamma-picolinium chloride, topical powder.
