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: "524.1195"
section_subject: "Ivermectin otic suspension."
cfr_reference: "21 CFR 524.1195"
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 0.5 milliliter (mL) of a 0.01 percent suspension of ivermectin.
(b)Sponsor. See No. 000010 in § 510.600(c) of this chapter.
(c)Conditions of use—(1) Amount. Administer the contents of one 0.5-mL tube topically into each external ear canal.
(2)Indications for use. For the treatment of adult ear mite (Otodectes cynotis) infestations in cats and kittens 4 weeks of age and older. Effectiveness against eggs and immature stages has not been proven.
(3)Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.