[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: 21CFR524.1195]

[Page 305]
 
                        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.  524.1195  Ivermectin otic suspension.

    (a) Specifications. Each tube contains 0.5 milliliter (mL) of a 0.01 
percent suspension of ivermectin.
    (b) Sponsor. See No. 065274 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer the contents of one 
0.5-mL tube topically into each external ear canal.
    (2) Indications for use. For the treatment of adult ear mite 
(Otodectes cynotis) infestations in cats and kittens 4 weeks of age and 
older. Effectiveness against eggs and immature stages has not been 
proven.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[66 FR 7578, Jan. 24, 2001]