21 CFR 524.1140

§ 524.1140 Imidacloprid and ivermectin.

United States · 21 CFR — Food and Drugs · Status: effective

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Citation: 21 CFR 524.1140, § 524.1140 Imidacloprid and ivermectin, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87612
Permanent ID: ys:prov:87612@1
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Full text

(a) Specifications. The product is available in unit applicator tubes containing 0.4, 1.0, 2.5, or 4.0 milliliters (mL). Each mL of solution contains 100 milligrams (mg) imidacloprid and 800 micrograms (µg) ivermectin. (b) Sponsor. See No. 058198 in § 510.600(c) of this chapter. (c) Conditions of Use in Dogs—(1) Amount. The recommended minimum dosage is 4.5 mg/pound (lb) (10 mg/kilogram (kg)) of imidacloprid and 36.4 µg/lb (80 µg/kg) of ivermectin, topically once a month. (2) Indications for Use. For the prevention of heartworm disease caused by Dirofilaria immitis; kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis). (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.