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Title 21: Food and Drugs
§ 520.1638 Oxibendazole.

(a) Specifications - (1) Each gram of paste contains 227 milligrams (mg) (22.7 percent) oxibendazole.

(2) Each milliliter of suspension contains 100 mg (10 percent) oxibendazole.

(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.

(c) Special considerations - (1) See § 500.25 of this chapter.

(2) Suspension product described in paragraph (a)(2) of this section shall be labeled: “Federal law restricts this drug to use by or on the order of a licensed veterinarian.”

(d) Conditions of use in horses - (1) Amount. For uses other than for threadworms (Strongyloides westeri), 10 mg oxibendazole per kilogram (/kg) body weight; for threadworms (Strongyloides westeri), 15 mg/kg. Horses maintained on premises where reinfection is likely to occur should be re-treated in 6 to 8 weeks. Administer suspension product by stomach tube in 3 to 4 pints of warm water, or by top dressing or mixing into a portion of the normal grain ration.

(2) Indications for use. For removal and control of large strongyles (Strongylus edentatus, S. equinus, S. vulgaris); small strongyles (genera Cylicostephanus, Cylicocyclus, Cyathostomum, Triodontophorus, Cylicodontophorus, and Gyalocephalus); large roundworms (Parascaris equorum); pinworms (Oxyuris equi) including various larval stages; and threadworms (Strongyloides westeri).

(3) Limitations. Do not use in horses intended for human consumption.

[78 FR 28825, May 20, 2014]
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