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Electronic Code of Federal Regulations

e-CFR data is current as of December 12, 2019

Title 21Chapter ISubchapter EPart 524 → §524.1600b


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


§524.1600b   Nystatin, neomycin, thiostrepton, and triamcinolone 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) Related tolerances. See §§556.430 and 556.470 of this chapter.

(d) Conditions of use—(1) Dogs and cats—(i) Amount. Apply 1 drop of ointment to the affected eye(s) 2 or 3 times daily. Treatment may be continued for up to 2 weeks if necessary.

(ii) Indications for use. For use as an anti-inflammatory, antipruritic, antifungal (Candida albicans), and antibacterial ointment for local therapy in keratitis and conjunctivitis.

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

(2) Cattle—(i) Amount. Apply small line of ointment to the affected eye(s) once daily. Treatment may be continued for up to 2 weeks if necessary.

(ii) Indications for use. For infectious kerato-conjunctivitis (pinkeye).

(iii) Limitations. 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 50 FR 41490, Oct. 11, 1985; 79 FR 10972, Feb. 27, 2014; 84 FR 32993, July 11, 2019]

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