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Code · CFR · Title 21 — Food and Drugs · Part 524 — Ophthalmic and Topical Dosage Form New Animal Drugs · § 524.1600b

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

205 words·~1 min read·/us/cfr/t21/s§ 524.1600b·

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(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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