[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: 21CFR524.1044d]

[Page 302-303]
 
                        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.  524.1044d  Gentamicin sulfate, betamethasone valerate ointment.

    (a) Specifications. Each gram of ointment contains gentamicin 
sulfate equivalent to 3 milligrams of gentamicin base and betamethasone 
valerate equivalent to 1 milligram of betamethasone.
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used or indicated for use in 
dogs in the treatment of acute and chronic canine otitis externa and 
canine infected superficial lesions caused by bacteria sensitive to 
gentamicin.
    (2)(i) For the treatment of acute and chronic canine otitis externa 
the drug is administered by instillation of 3 to 8 drops into the ear 
canal twice daily for 7 days. The external ear and ear canal should be 
properly cleaned and dried before treatment. Remove foreign material, 
debris, crusted exudates, etc., with suitable nonirritating solutions. 
Excessive hair should be clipped from the treatment area of the external 
ear.
    (ii) For the treatment of canine infected superficial lesions, the 
lesion and adjacent area should be properly cleaned before treatment. 
Excessive hair should be removed. A sufficient

[[Page 303]]

amount of the drug should be applied to cover the treatment area. The 
drug should be administered twice daily for 7 to 14 days.
    (3) If hypersensitivity to any of the components occurs, treatment 
should be discontinued and appropriate therapy instituted. Concomitant 
use of drugs known to induce ototoxicity should be avoided. Observe 
patients for signs of adrenocorticoid overdosage. 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) For use by or on the order of a licensed veterinarian.

[47 FR 26378, June 18, 1982, as amended at 52 FR 7832, Mar. 13, 1987]