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21 C.F.R. § 524.1140   Imidacloprid and ivermectin.

Title 21 - Food and Drugs

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

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§ 524.1140   Imidacloprid and ivermectin.

(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. 000859 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]

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