21 CFR 524.981e

§ 524.981e Fluocinolone and dimethyl sulfoxide otic solution.

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

Cite this

Citation: 21 CFR 524.981e, § 524.981e Fluocinolone and dimethyl sulfoxide otic solution, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87597
Permanent ID: ys:prov:87597@1
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Full text

(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.

Legislative history

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