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Code of Federal Regulations (Last Updated: May 6, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter E - Animal Drugs, Feeds, and Related Products |
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Part 524 - Ophthalmic and Topical Dosage Form New Animal Drugs |
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Fluocinolone Topical and Otic Dosage Forms |
§ 524.1195 - Ivermectin otic suspension.
Latest version.
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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. 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]