CFR - Code of Federal Regulations Title 21

The information on this page is current as of Mar 22, 2024.

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: 21CFR524.981c]

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. 524.981c Fluocinolone and neomycin cream.

(a) Specifications. The drug contains 0.025 percent fluocinolone acetonide and 0.5 percent neomycin sulfate (0.35 percent neomycin base).

(b) Sponsor. See No. 099207 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs - (1) Amount. A small amount is applied to the affected area two or three times daily.

(2) Indications for use - (i) Dogs. For the relief of pruritis and inflammation associated with superficial acute and chronic dermatoses. It is used in the treatment of allergic and acute moist dermatitis and nonspecific dermatoses.

(ii) Dogs and cats. Used in the treatment of wound infections.

(3) 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 62 FR 40932, July 31, 1997; 79 FR 10969, Feb. 27, 2014]