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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Oct 01, 2021.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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[Code of Federal Regulations]
[Title 21, Volume 6]
[CITE: 21CFR520.1629]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 520 -- ORAL DOSAGE FORM NEW ANIMAL DRUGS

Sec. 520.1629 Oxfendazole paste.

(a)(1) Specifications. Each gram of paste contains 0.375 gram oxfendazole (37.5 percent).

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

(3) Conditions of use - (i) Amount. 10 milligrams per kilogram (2.2 pounds) of body weight.

(ii) Indications for use. The drug is used in horses for removal of the following gastrointestinal worms: 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. 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. Not for use in horses intended for food. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

(b)(1) Specifications. Each gram of paste contains 185 milligrams of oxfendazole (18.5 percent).

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

(3) Related tolerances. See § 556.495 of this chapter.

(4) Conditions of use - (i) Amount. 4.5 milligrams per kilogram of body weight (2.05 milligrams per pound).

(ii) Indications for use. The drug is used in cattle for the removal and control of the following worms: 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. Treatment may be repeated in 4 to 6 weeks. Cattle must not be slaughtered until 11 days after treatment. Do not use in female dairy cattle of breeding age. Consult a veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[49 FR 38250, Sept. 28, 1984, as amended at 58 FR 39443, July 23, 1993; 61 FR 5506, Feb. 13, 1996; 78 FR 28825, May 20, 2014]

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