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: "524.955"
section_subject: "Florfenicol, terbinafine, and betamethasone acetate otic gel."
cfr_reference: "21 CFR 524.955"
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 gel contains 10 milligrams (mg) florfenicol, 10 mg terbinafine, and 1 mg betamethasone acetate.
(b)Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c)Conditions of use in dogs—(1) Amount. Administer one dose (1 tube) per affected ear(s) and repeat administration in 7 days.
(2)Indications for use. For the treatment of otitis externa in dogs associated with susceptible strains of bacteria (Staphylococcus pseudintermedius) and yeast (Malassezia pachydermatis).
(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.