21 CFR § 524.1195 - Ivermectin otic suspension.

---
identifier: "/us/cfr/t21/s524.1195"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 524.1195 - Ivermectin otic suspension."
title_number: 21
title_name: "Food and Drugs"
section_number: "524.1195"
section_name: "Ivermectin otic suspension."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "E"
subchapter_name: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_number: "524"
part_name: "OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 360b."
regulatory_source: "40 FR 13873, Mar. 27, 1975, unless otherwise noted."
cfr_part: "524"
---


# 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]