21 C.F.R. § 520.1638

Current through October 31, 2024
Section 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.

21 C.F.R. §520.1638

78 FR 28825 , May 20, 2014