[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: 21CFR524.1044f]

[Page 303]
 
                        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.  524.1044f  Gentamicin sulfate, betamethasone valerate topical spray.

    (a) Specifications. Each milliliter of spray contains gentamicin 
sulfate equivalent to 0.57 milligram of gentamicin base and 
betamethasone valerate equivalent to 0.284 milligram of betamethasone.
    (b) Sponsor. See Nos. 000061 and 051259 in Sec.  510.600(c) of this 
chapter.
    (c) Conditions of use. (1) The drug is used in dogs in the treatment 
of infected superficial lesions caused by bacteria sensitive to 
gentamicin.
    (2) For the treatment of infected superficial lesions, the lesion 
and adjacent area should be properly cleaned before treatment. Excessive 
hair should be removed. Hold bottle upright 3 to 6 inches from the 
lesion and depress the sprayer head twice. One actuation of the sprayer 
delivers 0.7 milliliter of the spray. The drug should be administered 
with two spray actuations 2 to 4 times daily for 7 days.
    (3) If hypersensitivity to any of the components occurs, treatment 
should be discontinued and appropriate therapy instituted. The 
antibiotic susceptibility of the pathogenic organism should be 
determined prior to use of this preparation. Administration of 
recommended doses beyond 7 days may result in delayed wound healing. 
Animals treated longer than 7 days should be monitored closely.
    (4) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[50 FR 740, Jan. 7, 1985, as amended at 52 FR 7833, Mar. 13, 1987; 62 FR 
10220, Mar. 6, 1997]