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Code · CFR · Title 21 — Food and Drugs · Part 520 — Oral Dosage Form New Animal Drugs · § 520.905c

§ 520.905c. Fenbendazole paste.

398 words·~2 min read·/us/cfr/t21/s§ 520.905c·

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

(a)Specifications. Each gram of paste contains 100 milligrams
(mg)fenbendazole (10 percent).
(b)Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(c)Related tolerances. See § 556.275 of this chapter.
(d)Special considerations. See § 500.25 of this chapter.
(e)Conditions of use—(1) Horses—(i) Indications for use and amounts.
(A)For the treatment and control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris), small strongyles, and pinworms (Oxyuris equi). For large strongyles, small strongyles, and pinworms, the recommended dose is 5 mg/kg (2.3 mg/lb).
(B)For treatment and control of ascarids (Parascaris equorum). For ascarids, the recommended dose is 10 mg/kg (4.6 mg/lb).
(C)For treatment and control of hypobiotic (encysted early third-stage), late third-stage, and fourth-stage cyathostome larvae, as well as fourth-stage Strongylus vulgaris larvae, the recommended dose is 10 mg/kg (4.6 mg/lb) daily for 5 consecutive days.
(D)For the control of arteritis caused by fourth-stage larvae of Strongylus vulgaris in horses.
(E)Fenbendazole paste 10 percent may be used concomitantly with approved forms of trichlorfon for the indications provided in paragraph (e)(1)(i)(A) of this section and for treating infections of stomach bots as provided in § 520.2520.
(ii)Limitations. Do not use in horses intended for human consumption.
(2)Beef and dairy cattle—(i) Amount. Administer orally 2.3 mg/lb (5 mg/kg) body weight.
(ii)Indications for use. For the treatment and control of: Lungworms: Adult (Dictyocaulus viviparus); Stomach worms: Adult brown stomach worms (Ostertagia ostertagi), adult and fourth-stage larvae barberpole worms (Haemonchus contortus), fourth-stage larvae barberpole worms (H. placei), and adult and fourth-stage larvae small stomach worms (Trichostrongylus axei); Intestinal worms (adult and fourth-stage larvae): Hookworms (Bunostomum phlebotomum), thread-necked intestinal worms (Nematodirus helvetianus), small intestinal worms (Cooperia punctata and C. oncophora), bankrupt worms (Trichostrongylus colubriformis), and nodular worms (Oesophagostomum radiatum).
(iii)Limitations. Milk taken during treatment and for 96 hours after the last treatment must not be used for human consumption. Cattle must not be slaughtered for human consumption within 8 days following last treatment with this drug product. Not for use in beef calves less than 2 months of age, dairy calves, and veal calves. A withdrawal period has not been established for this product in preruminating calves. [72 FR 24185, May 2, 2007, as amended at 74 FR 61516, Nov. 25, 2009; 76 FR 17337, Mar. 29, 2011; 86 FR 57996, Oct. 20, 2021; 87 FR 10968, Feb. 28, 2022]
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