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e-CFR data is current as of February 25, 2021

Title 21Chapter ISubchapter EPart 524 → §524.1600a

Title 21: Food and Drugs

§524.1600a   Nystatin, neomycin, thiostrepton, and triamcinolone ointment.

(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 Nos. 000856, 025463, 054771, and 054925 in §510.600(c) of this chapter. For vanishing cream base ointments see Nos. 025463, 054771, 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. 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; 79 FR 10972, Feb. 27, 2014]

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