21 CFR 524.1195
§ 524.1195 Ivermectin otic suspension.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 524.1195, § 524.1195 Ivermectin otic suspension, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87616
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.