Code of Federal Regulations · Section
§ 524.1195 — Ivermectin Otic Suspension
21 C.F.R. § 524.1195
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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.
Authorizing Statute
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New animal drugs21 U.S.C. § 360b