21 C.F.R. § 524.1140

Current through May 31, 2024
Section 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 ([MICRO]g) 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 [MICRO]g/lb (80 [MICRO]g/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.

21 C.F.R. §524.1140

67 FR 78685, Dec. 26, 2002, as amended at 86 FR 14821, Mar. 19, 2021
86 FR 14821, 3/19/2021