21 CFR § 524.981b - Fluocinolone solution.
---
identifier: "/us/cfr/t21/s524.981b"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 524.981b - Fluocinolone solution."
title_number: 21
title_name: "Food and Drugs"
section_number: "524.981b"
section_name: "Fluocinolone solution."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "524"
part_name: "OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13873, Mar. 27, 1975, unless otherwise noted."
cfr_part: "524"
---
# 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]