21 C.F.R. § 524.1600b   Nystatin, neomycin, thiostrepton, and triamcinolone acetonide ophthalmic ointment.


Title 21 - Food and Drugs


Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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§ 524.1600b   Nystatin, neomycin, thiostrepton, and triamcinolone acetonide ophthalmic ointment.

(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]

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