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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2019.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2019]
[CITE: 21CFR524.1195]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E--ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 524 -- OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 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]

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