21 CFR § 524.981e - Fluocinolone and dimethyl sulfoxide otic solution.

---
identifier: "/us/cfr/t21/s524.981e"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 524.981e - Fluocinolone and dimethyl sulfoxide otic solution."
title_number: 21
title_name: "Food and Drugs"
section_number: "524.981e"
section_name: "Fluocinolone and dimethyl sulfoxide otic 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"
---


# 524.981e Fluocinolone and dimethyl sulfoxide otic solution.

(a) *Specifications.* Each milliliter of solution contains 0.01 percent fluocinolone acetonide and 60 percent dimethyl sulfoxide.

(b) *Sponsor.* See No. 054771 in § 510.600(c) of this chapter.

(c) *Conditions of use in dogs*—(1) *Amount.* Instill 4 to 6 drops (0.2 milliliter) twice daily into the ear canal for a maximum period of 14 days. The total dosage used should not exceed 17 milliliters.

(2) *Indications for use.* For the relief of pruritis and inflammation associated with acute and chronic otitis.

(3) *Limitations.* Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 10969, Feb. 27, 2014]