21 CFR § 524.1140 Ophthalmic and Topical Dosage Form New Animal Drugs

§ 524.1140 Imidacloprid and ivermectin.

Current through Sep 8, 2026 · Read all of Part 524

(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.

[67 FR 78685, Dec. 26, 2002, as amended at 86 FR 14821, Mar. 19, 2021]

← § 524.1132 Hydrocortisone, miconazole, and gentamicin otic suspension.§ 524.1144j Gentamicin, posaconazole, and mometasone furoate otic suspension. →