21 C.F.R. § 524.981b Fluocinolone acetonide solution.
Title 21 - Food and Drugs
(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. [40 FR 13873, Mar. 27, 1975, as amended at 62 FR 40932, July 31, 1997]
Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
§ 524.981b Fluocinolone acetonide solution.
