[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR524.1044g]

[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. 524.1044g  Gentamicin sulfate, betamethasone valerate, clotrimazole ointment.

    (a) Specifications. Each gram (g) of ointment contains gentamicin 
sulfate equivalent to 3 milligrams (mg) gentamicin base, betamethasone 
valerate equivalent to 1 mg betamethasone, and 10 mg clotrimazole.
    (b) Sponsors. See sponsors in Sec. 510.600(c) of this chapter for 
uses as in paragraph (c) of this section.
    (1) No. 000061 for use of 7.5- or 15-gram (g) tubes, 12.5-, 30-, or 
215-g bottles.
    (2) No. 051259 for use of 7.5- or 15-g tubes, 10-, or 25-g bottles.
    (3) No. 059130 for use of 10- or 215-g bottles.
    (c) Conditions of use in dogs--(1) Amount. Instill ointment twice 
daily into the ear canal. Therapy should continue for 7 consecutive 
days.
    (i) From 7.5- or 15-g tubes, 10-, 12.5-, 25-, or 30-g bottles: 4 
drops for dogs weighing less than 30 pounds (lb) or 8 drops for dogs 
weighing 30 lb or more.
    (ii) From 215-g bottles: 2 drops for dogs weighing less than 30 lb 
or 4 drops for dogs weighing 30 lb or more.
    (2) Indications for use. For the treatment of canine otitis externa 
associated with yeast (Malassezia pachydermatis, formerly Pityrosporum 
canis) and/or bacteria susceptible to gentamicin.
    (3) Limitations. Federal law restricts this drug to use by or on the 
order of a licensed veterinarian.

[58 FR 38973, July 21, 1993, as amended at 63 FR 31932, June 11, 1998; 
68 FR 42970, July 21, 2003]