21 C.F.R. § 520.1630 Oxfendazole suspension.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter contains 90.6 or 225.0 milligrams oxfendazole (9.06 or 22.5 percent). (b) Sponsor. See 000856 in §510.600(c) of this chapter. (c) Related tolerances. See §556.495 of this chapter. (d) Conditions of use—(1) Horses (9.06 percent suspension only). (i) Amount. 10 milligrams per kilogram (2.2 pounds) of body weight. (ii) Indications for use. For removal of large roundworms (Parascaris equorum), mature and 4th stage larvae pinworms (Oxyuris equi), large strongyles (Strongylus edentatus, S. vulgaris, and S. equinus), and small strongyles. (iii) Limitations. Administer 9.06 percent suspension by stomach tube or dose syringe. Horses maintained on premises where reinfection is likely to occur should be retreated in 6 to 8 weeks. Withholding feed or water prior to use is unnecessary. Administer drug with caution to sick or debilitated horses. Do not use in horses intended for food. If administered by stomach tube: Federal law restricts this drug to use by or on the order of a licensed veterinarian. If administered by dose syringe only: Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. (2) Cattle. (9.06 or 22.5 percent suspension). (i) Amount. 4.5 milligrams per kilogram of body weight (2.05 milligrams per pound). (ii) Indications for use. For the removal and control of: lungworms (Dictyocaulus viviparus—adult, L4); stomach worms: barberpole worms (Haemonchus contortus and H. placei—adult), small stomach worms (Trichostrongylus axei—adult), brown stomach worms (Ostertagia ostertagi—adult, L4, inhibited L4); intestinal worms; nodular worms (Oesophagostomum radiatum—adult), hookworms (Bunostomum phlebotomum—adult), small intestinal worms (Cooperia punctata, C. oncophora, and C. mcmasteri—adult, L4), and tapeworms (Moniezia benedeni—adult). (iii) Limitations. For use in cattle only. Administer 9.06 percent suspension orally only with a dose syringe, and 22.5 percent suspension either orally with a dose syringe or intraruminally with a rumen injector. Treatment may be repeated in 4 to 6 weeks. Cattle must not be slaughtered until 7 days after treatment. Do not use in lactating dairy cattle. For use of 9.06 percent suspension orally: Consult a veterinarian for assistance in the diagnosis, treatment, and control of parasitism. For use of 22.5 percent suspension orally or intraruminally: Federal law restricts this drug to use by or on the order of a licensed veterinarian. [55 FR 46943, Nov. 8, 1990, as amended at 56 FR 8710, Mar. 1, 1991; 61 FR 5506, Feb. 13, 1996]
Title 21: Food and Drugs
PART 520—ORAL DOSAGE FORM NEW ANIMAL DRUGS
§ 520.1630 Oxfendazole suspension.
