Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024
§ 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]
authority: 21 U.S.C. 360b.
source: 40 FR 13873, Mar. 27, 1975, unless otherwise noted.
cite as: 21 CFR 524.981b