CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 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: 21CFR524.981b]

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. 524.981b Fluocinolone solution.

(a) Specifications. The drug contains 0.01 percent fluocinolone acetonide.

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

(c) Conditions of use in dogs - (1) Amount. A small amount of solution 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 otitis externa and certain superficial acute and chronic dermatoses.

(ii) Cats. For the relief of pruritis and inflammation associated with acute otitis externa and certain superficial acute and chronic dermatoses.

(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]