21 C.F.R. § 520.905c Fenbendazole paste.
Title 21 - Food and Drugs
(a) Specifications. The product is an aqueous paste containing 10 percent fenbendazole. (b) Sponsor. See No. 057926 in §510.600(c) of this chapter. (c) Related tolerances. See §556.275 of this chapter. (d) Conditions of use—(1) Horses—(i)(a) Amount. 2.3 milligrams per pound of body weight (one 2.5-gram fenbendazole syringe for a 1,100-pound horse). For foals and weanlings (less than 18 months of age), 4.6 milligrams per pound of body weight (one 2.5-gram fenbendazole syringe for each 550 pounds of body weight). (b) Indications for use. For control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris), small strongyles, pinworms (Oxyuris equi), and ascarids (Parascaris equorum) in horses. (c) Limitations. Retreatment at intervals of 6 to 8 weeks may be required. Do not use in horses intended for food. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. (ii)(a) Amount. 4.6 milligrams per pound of body weight (one 2.5-gram fenbendazole syringe for a 550-pound horse) daily for 5 days. (b) Indications for use. For control of arteritis caused by the fourth stage larvae of Strongylus vulgaris. (c) Limitations. Treatment should be initiated in the spring and repeated in 6 months. Do not use in horses intended for food. Consult your veterinarian for assistance in the diagnosis, treatment, and control of fourth stage larvae of S. vulgaris. (iii)(a) Amount. 4.6 milligrams per pound of body weight (10 milligrams per kilogram) daily for 5 consecutive days. (b) Indications for use. For treatment of encysted mucosal cyathostome (small strongyle) larvae including early third stage (hypobiotic), late third stage, and fourth stage larvae in horses. (c) Limitations. (Consult your veterinarian for assistance in the diagnosis, treatment, and control of encysted mucosal cyathostomes). Do not use in horses intended for food. (2) Beef and dairy cattle—(i) Amount. Administer orally 5 milligrams per kilogram of body weight (2.3 milligrams per pound). (ii) Indications for use. For the removal and control of lungworm (Dictyocaulus viviparus), barberpole worm (Haemonchus contortus), brown stomach worm (Ostertagia ostertagi), small stomach worm (Trichostrongylus axei), hookworm (Bunostomum phlebotomum), thread-necked intestinal worm (Nematodirus helvetianus), small intestinal worms (Cooperia punctata and C. oncophora), bankrupt worm (Trichostrongylus colubriformis), and nodular worm (Oesophagostomum radiatum). (iii) Limitations. Re-treatment may be needed after 4 to 6 weeks. Cattle must not be slaughtered within 8 days following last treatment. Consult a veterinarian for assistance in the diagnosis, treatment, and control of parasitism. (e) Special considerations. Fenbendazole paste 10 percent may be used concomitantly with approved forms of trichlorfon for the indications provided in paragraph (d)(1)(i) of this section and for treating infections of stomach bots as provided in §520.2520. [46 FR 32018, June 19, 1981, as amended at 47 FR 15327, Apr. 9, 1982; 49 FR 8433, Mar. 7, 1984; 50 FR 26358, June 26, 1985; 61 FR 29478, June 11, 1996; 63 FR 31624, June 10, 1998; 66 FR 47960, Sept. 17, 2001]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.905c Fenbendazole paste.
