§524.1195. Ivermectin otic suspension.
21 C.F.R. § 524.1195
Specifications. Each tube contains 0.5 milliliter (mL) of a 0.01 percent suspension of ivermectin.
Sponsor. See No. 000010 in § 510.600(c) of this chapter.
Conditions of use—
Amount. Administer the contents of one 0.5-mL tube topically into each external ear canal.
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.
Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Notes, amendments, and revision history
Amendments
[66 FR 7578, Jan. 24, 2001, as amended at 74 FR 26782, June 4, 2009]
Authority
Authority: 21 U.S.C. 360b.
Source
Source: 40 FR 13873, Mar. 27, 1975, unless otherwise noted.
Amendments
[66 FR 7578, Jan. 24, 2001, as amended at 74 FR 26782, June 4, 2009]