Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024
§ 524.1195 - Ivermectin otic suspension.

(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.

[66 FR 7578, Jan. 24, 2001, as amended at 74 FR 26782, June 4, 2009]
authority: 21 U.S.C. 360b.
source: 40 FR 13873, Mar. 27, 1975, unless otherwise noted.
cite as: 21 CFR 524.1195