subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "524"
part_subject: "OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS"
subpart_code: "B"
subpart_subject: "Specific Administrative Rulings and Decisions"
section_number: "524.981e"
section_subject: "Fluocinolone and dimethyl sulfoxide otic solution."
cfr_reference: "21 CFR 524.981e"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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.