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

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. 065274 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]