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21 C.F.R. § 524.1195   Ivermectin otic suspension.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 524—OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

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§ 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]

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