21 CFR 524.981b

§ 524.981b Fluocinolone solution.

United States · 21 CFR — Food and Drugs · Status: effective

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Citation: 21 CFR 524.981b, § 524.981b Fluocinolone solution, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87594
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Full text

(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.