21 C.F.R. § 524.1146
Imidacloprid and moxidectin.
Cite as 21 C.F.R. § 524.1146 (2026)
(a)
Specifications.
Each milliliter of solution contains:
(1) 100 milligrams (mg) imidacloprid and 25 mg moxidectin; or
(2) 100 mg imidacloprid and 10 mg moxidectin.
(b)
Sponsors.
See sponsor numbers in § 510.600(c) of this chapter as follows:
(1) Nos. 017030, 051072, 051311, 055529, 058198, and 061133for use of product described in paragraph (a)(1) of this section as in paragraph (d)(1) of this section.
(2) Nos. 017030, 051072, 051311, 055529, 058198, and 061133 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(2) of this section.
(3) Nos. 051072, 055529, 058198, 061133, and 061651 for use of product described in paragraph (a)(2) of this section as in paragraph (d)(3) of this section.
(c)
Special considerations.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d)
Conditions of use
—(1)
Dogs
—(i)
Amount.
Topically apply 4.5 mg/lb body weight (10 mg/kg) imidacloprid and 1.1 mg/lb (2.5 mg/kg) moxidectin, once a month.
(ii)
Indications for use.
(A) For the prevention of heartworm disease caused by
Dirofilaria immitis
; and the treatment and control of intestinal roundworms (
Toxocara canis
and
Toxascaris leonina
), hookworms (
Ancylostoma caninum
and
Uncinaria stenocephala
), and whipworms (
Trichuris vulpis
); kills adult fleas and treats flea infestations (
Ctenocephalides felis
).
(B) For treatment of
Dirofilaria immitis
circulating microfilariae in heartworm-positive dogs and the treatment and control of sarcoptic mange caused by
Sarcoptes scabiei
var.
canis.
(2)
Cats
—(i)
Amount.
Topically apply 4.5 mg/lb body weight (10 mg/kg) imidacloprid and 0.45 mg/lb (1.0 mg/kg) moxidectin, once a month.
(ii)
Indications for use.
For the prevention of heartworm disease caused by
Dirofilaria immitis
; for the treatment and control of ear mite (
Otodectes cynotis
) infestations, intestinal roundworms (
Toxocara cati
), and hookworms (
Ancylostoma tubaeforme
); kills adult fleas and treats flea infestations (
Ctenocephalides felis
).
(3)
Ferrets
—(i)
Amount.
Topically apply 9.0 mg/lb body weight (20 mg/kg) imidacloprid and 0.9 mg/lb (2 mg/kg) moxidectin, once a month.
(ii)
Indications for use.
For the prevention of heartworm disease caused by
Dirofilaria immitis
; kills adult fleas (
Ctenocephalides felis
) and is indicated for the treatment of flea infestations on ferrets.
[72 FR 10597, Mar. 9, 2007, as amended at 78 FR 73698, Dec. 9, 2013; 85 FR 18120, Apr. 1, 2020; 86 FR 13185, Mar. 8, 2021; 86 FR 14821, Mar. 19, 2021; 87 FR 17946, Mar. 29, 2022; 87 FR 58963, Sept. 29, 2022; 88 FR 27700, May 3, 2023; 89 FR 14410, Feb. 27, 2024; 90 FR 40970, Aug. 22, 2025]
- Cross-references to the CFR
- 510.600