21 C.F.R. § 524.1195

Current through May 31, 2024
Section 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.

21 C.F.R. §524.1195

66 FR 7578, Jan. 24, 2001, as amended at 74 FR 26782, June 4, 2009