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]