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: "524.1044g"
section_subject: "Gentamicin, betamethasone, and clotrimazole ointment."
cfr_reference: "21 CFR 524.1044g"
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 gram (g) of ointment contains gentamicin sulfate equivalent to 3 milligrams (mg) gentamicin base, betamethasone valerate equivalent to 1 mg betamethasone, and 10 mg clotrimazole.
(b)Sponsors. See sponsors in § 510.600(c) of this chapter for uses as in paragraph (c) of this section.
(1)No. 000061 for use of 7.5- or 15-gram (g) tubes, 12.5-, 30-, or 215-g bottles.
(2)No. 054925 for use of 7.5- or 15-g tubes; 10-, 15-, 25-, or 215-g bottles.
(3)No. 069043 for use of 10-, 20-, 40-, or 215-g bottles.
(4)No. 025463 for use of 7.5- or 15-g tubes, or 215-g bottles.
(c)Conditions of use in dogs—(1) Amount. Instill ointment twice daily into the ear canal for 7 consecutive days.
(i)From 7.5- or 15-g tubes; 10-, 12.5-, 15-, 25-, or 30-g bottles: 4 drops for dogs weighing less than 30 pounds (lb) or 8 drops for dogs weighing 30 lb or more.
(ii)From 20-, 40-, or 215-g bottles: 2 drops for dogs weighing less than 30 lb or 4 drops for dogs weighing 30 lb or more.
(ii)From 20- or 215-g bottles: 2 drops for dogs weighing less than 30 lb or 4 drops for dogs weighing 30 lb or more.
(2)Indications for use. For the treatment of acute and chronic canine otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.
(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.