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: "524.957"
section_subject: "Florfenicol, terbinafine, and mometasone otic solution."
cfr_reference: "21 CFR 524.957"
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 single-dose, prefilled dropperette contains 1 milliliter (mL) of a solution containing 16.6 milligrams (mg) florfenicol, 14.8 mg terbinafine (equivalent to 16.6 mg terbinafine hydrochloride), and 2.2 mg mometasone furoate.
(b)Sponsor. See No. 000859 in § 510.600(c) of this chapter.
(c)Conditions of use in dogs—(1) Amount. Administer one dropperette (1 mL) per affected ear(s).
(2)Indications for use. For the treatment of otitis externa in dogs associated with susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Staphylococcus pseudintermedius).
(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.