CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

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

[Code of Federal Regulations]

[Title 21, Volume 6]

[CITE: 21CFR520.1326b]

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. 520.1326b Mebendazole and trichlorfon paste.

(a) Specifications. Each gram of paste contains 100 milligrams of mebendazole and 454 milligrams of trichlorfon.

(b) Sponsor. See No. 000061 in § 510.600(c) of this chapter.

(c) Conditions of use in horses - (1) Amount. 8.8 milligrams of mebendazole and 40 milligrams of trichlorfon per kilogram of body weight.

(2) Indications for use. It is used in horses for treatment of infections of bots (Gastrophilus intestinalis and G. nasalis ), large roundworms (Parascaris equorum ), large strongyles (Strongylus edentatus, S. equinus, S. vulgaris ), small strongyles, and pinworms (Oxyuris equi ).

(3) Limitations. Do not administer more than once every 30 days. Do not treat sick or debilitated animals, foals under 4 months of age, or mares in the last month of pregnancy. Trichlorfon is a cholinesterase inhibitor. Do not administer simultaneously or within a few days before or after treatment with, or exposure to, cholinesterase-inhibiting drugs, pesticides, or chemicals. Do not administer intravenous anesthetics, especially muscle relaxants, concurrently. Not for use in horses intended for food. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

[51 FR 13212, Apr. 18, 1986, as amended at 62 FR 61625, Nov. 19, 1997; 78 FR 28824, May 20, 2014]