[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR524.1140]

[Page 304]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
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 
([mu]g) ivermectin.
    (b) Sponsor. See No. 000859 in Sec.  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 [mu]g/lb (80 [mu]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]