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: 21CFR524.1140]

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 524 -- OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

Fluocinolone Topical and Otic Dosage Forms

Sec. 524.1140 Imidacloprid and ivermectin.

(a) Specifications. The product is available in unit applicator tubes containing 0.4, 1.0, 2.5, or 4.0 milliliters (mL). Each mL of solution contains 100 milligrams (mg) imidacloprid and 800 micrograms ([micro]g) ivermectin.

(b) Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c) Conditions of Use in Dogs - (1) Amount. The recommended minimum dosage is 4.5 mg/pound (lb) (10 mg/kilogram (kg)) of imidacloprid and 36.4 [micro]g/lb (80 [micro]g/kg) of ivermectin, topically once a month.

(2) Indications for Use. For the prevention of heartworm disease caused by Dirofilaria immitis ; kills adult fleas and is indicated for the treatment of flea infestations (Ctenocephalides felis ).

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[67 FR 78685, Dec. 26, 2002, as amended at 86 FR 14821, Mar. 19, 2021]