Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 524  /  Sec. 524.1600 Nystatin ophthalmic and topical 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. For petrolatum base ointments see Nos. 000856, 025463, 054771, and 054925 in Sec. 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.

(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.

(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.

(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] Sec. 524.1600b Nystatin, neomycin, thiostrepton, and triamcinoloneophthalmic 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 Sec. 510.600(c) of this chapter.

(c) 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.

(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.

(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.

(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]