CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR524.1600a]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 524 -- OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

Fluocinolone Topical and Otic Dosage Forms

Sec. 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. See sponsors in § 510.600(c) of this chapter:

(1) For petrolatum base ointments: Nos. 025463 and 054771; or

(2) For vanishing cream base ointments: Nos. 025463 and 054771.

(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; 88 FR 84701, Dec. 6, 2023]