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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 April 1 2019.

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

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2019]
[CITE: 21CFR524.815]



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

Sec. 524.815 Eprinomectin and praziquantel.

(a) Specifications. Each milliliter (mL) of solution contains 4 milligrams (mg) eprinomectin and 83 mg praziquantel.

(b) Sponsor. See No. 000010 in 510.600(c) of this chapter.

(c) Conditions of use in cats --(1) Amount. Using the 0.3 mL and 0.9 mL unit applicators, administer a minimum dose of 0.23 mg eprinomectin per pound body weight and 4.55 mg praziquantel per pound body weight by topical application on the dorsal midline between the base of the skull and the shoulder blades.

(2) Indications for use. For the prevention of heartworm disease caused by Dirofilaria immitis, and for the treatment and control of roundworms (adult and fourth stage larval Toxocara cati ), hookworms (adult and fourth stage larval Ancylostoma tubaeforme; adult Ancylostoma braziliense ), and tapeworms (adult Dipylidium caninum and Echinococcus multilocularis ), in cats and kittens 7 weeks of age and older and 1.8 lbs or greater.

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

[83 FR 48946, Sept. 28, 2018, as amended at 84 FR 39184, Aug. 9, 2019]

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