[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR524.1044h]

[Page 302]
 
                        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. 524.1044h  Gentamicin sulfate, mometasone furoate, clotrimazole otic suspension.

    (a) Specifications. Each gram contains gentamicin sulfate, United 
States Pharmacopeia (USP) equivalent to 3-milligram (mg) gentamicin 
base, mometasone furoate monohydrate equivalent to 1-mg mometasone, and 
10 mg clotrimazole, USP.
    (b) Sponsor. See No. 000061 in Sec. 510.6(c) of this chapter.
    (c) Conditions of use--Dogs--(1) Amount. For dogs weighing less than 
30 pounds (lb), instill 4 drops from the 5- and 30-gram (g) bottle into 
the ear canal (2 drops from the 215-g bottle) or, for dogs weighing 30 
lb or more, instill 8 drops from the 5- and 30-g bottle into the ear 
canal (4 drops from the 215-g bottle), twice daily for 7 days.
    (2) Indications for use. For the treatment of otitis externa 
associated with yeast (Malassezia pachydermatis) and/or bacteria 
susceptible to gentamicin in dogs.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[66 FR 712, Jan. 4, 2001]