CFR > 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 (parts 500 to 590) > PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS > 524.981b—Fluocinolone acetonide solution.

524.981b—Fluocinolone acetonide solution.

(a) Specifications. The drug contains 0.01 percent fluocinolone acetonide in propylene glycol with citric acid.
(b) Sponsor. See No. 099207 in § 510.600(c) of this chapter.
(c) Conditions of use. (1) The drug is indicated for the relief of pruritus and inflammation associated with otitis externa and certain superficial acute and chronic dermatoses in the dog. It is also indicated for the relief of pruritus and inflammation associated with acute otitis externa and certain superficial acute and chronic dermatoses in the cat.
(2) A small amount of solution is applied to the affected area 2 or 3 times daily.
(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Code of Federal Regulations

[40 FR 13873, Mar. 27, 1975, as amended at 62 FR 40932, July 31, 1997]