Title 21

SECTION 520.260

520.260 n-Butyl chloride.

§ 520.260 n-Butyl chloride.

(a) Specifications. Each capsule contains 221, 442, 884, or 1,768 milligrams (mg); or 4.42 grams of n-butyl chloride.

(b) Sponsors. See sponsors in § 510.600(c) of this chapter:

(1) No. 023851 for capsules containing 221, 442, 884, or 1,768 mg, or 4.42 grams (g); and

(2) No. 054771 for capsules containing 221 mg.

(c) Conditions of use in dogs - (1) Amount. Administer capsules orally based on body weight as follows:

(i) Capsules containing 221 mg: Under 5 pounds, 1 capsule per 1 1/4 pounds of body weight.

(ii) Capsules containing 442 mg: Under 5 pounds, 1 capsule per 2 1/2 pounds of body weight.

(iii) Capsules containing 884 mg:

(A) Under 5 pounds, 1 capsule;

(B) 5 to 10 pounds, 2 capsules;

(C) 10 to 20 pounds, 3 capsules;

(D) 20 to 40 pounds, 4 capsules;

(E) Over 40 pounds, 5 capsules.

(iv) Capsules containing 1,768 mg: Dogs weighing 5 to 10 pounds, 1 capsule.

(v) Capsules containing 4.42 g: Dogs weighing 40 pounds or over, 1 capsule.

(2) Indications for use. For the removal of ascarids (Toxocara canis and Toxascaris leonina) and hookworms (Ancylostoma caninum, Ancylostoma braziliense, and Uncinaria stenocephala) from dogs.

(3) Limitations. Dogs should not be fed for 18 to 24 hours before being given the drug. Administration of the drug should be followed in 1/2 to 1 hour with a mild cathartic. Normal feeding may be resumed 4 to 8 hours after treatment. Animals subject to reinfection may be retreated in 2 weeks. A veterinarian should be consulted before using in severely debilitated dogs.

[86 FR 10819, Feb. 23, 2021]

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