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: "524.1446"
section_subject: "Milbemycin otic solution."
cfr_reference: "21 CFR 524.1446"
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 tube contains 0.25 milliliter of a 0.1 percent solution of milbemycin oxime.
(b)Sponsor. See No. 058198 in § 510.600(c) of this chapter.
(c)Conditions of use—(1) Amount. One tube administered topically into each external ear canal.
(2)Indications for use. For the treatment of ear mite (Otodectes cynotis) infestations in cats and kittens 4 weeks of age and older. Effectiveness is maintained throughout the life cycle of the ear mite.
(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.