CFR - Code of Federal Regulations Title 21

The information on this page is current as of Oct 17, 2023.

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: 21CFR524.1484b]

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. 524.1484b Neomycin, isoflupredone, and tetracaine powder.

(a) Specifications. Each 15-gram insufflator bottle contains 5 milligrams (mg) neomycin sulfate (equivalent to 3.5 mg neomycin base), 1 mg isoflupredone acetate, and 5 mg tetracaine hydrochloride in a powder base.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Conditions of use in horses, dogs, and cats - (1) Amount. Apply to affected areas as a dusting powder.

(2) Indications for use. For the treatment or as adjunctive therapy of certain ear and skin conditions caused by or associated with neomycin-susceptible organisms and/or allergy; as a superficial dressing applied to minor cuts, wounds, lacerations, abrasions, and for postsurgical application where reduction of pain and inflammatory response is deemed desirable; as a dusting powder following amputation of tails, claws, and dewclaws and following ear trimming, castrating, and such surgical procedures as ovariohysterectomies. For the treatment of acute otitis externa, acute moist dermatitis, and interdigital dermatitis in dogs.

(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 18172, Apr. 28, 1978; 79 FR 10970, Feb. 27, 2014; 85 FR 45308, July 28, 2020]