CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER E—ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS (parts 500 to 590) > PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS > 520.1200—Ivermectin, fenbendazole, and praziquantel tablets.

520.1200—Ivermectin, fenbendazole, and praziquantel tablets.

(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.

Code of Federal Regulations

[73 FR 33692, June 13, 2008, as amended by 74 FR 61516, Nov. 25, 2009]