21 C.F.R. § 520.1200
Ivermectin, fenbendazole, and praziquantel tablets.
Cite as 21 C.F.R. § 520.1200 (2026)
(a)
Specifications.
Each chewable tablet contains either:
(1) 68 micrograms (µg) ivermectin, 1.134 grams fenbendazole, and 57 milligrams (mg) praziquantel; or
(2) 27 µg ivermectin, 454 mg fenbendazole, and 23 mg praziquantel.
(b)
Sponsor.
See No. 000061 in § 510.600(c) of this chapter.
(c)
Conditions of use in dogs
—(1)
Amount.
Administer tablets to provide 6 µg per kilogram (/kg) ivermectin, 100 mg/kg fenbendazole, and 5 mg/kg praziquantel.
(2)
Indications for use.
For the treatment and control of adult
Toxocara canis
(roundworm),
Ancylostoma caninum
(hookworm),
Trichuris vulpis
(whipworm), and
Dipylidium caninum
(tapeworm), and for the prevention of heartworm disease caused by
Dirofilaria immitis
in adult dogs.
(3)
Limitations.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[73 FR 33692, June 13, 2008, as amended at 74 FR 61516, Nov. 25, 2009]
- Cross-references to the CFR
- 510.600