[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: 21CFR524.1044g]

[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. 524.1044g  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) Sponsor. See 000061 and 051259 in Sec. 510.600(c) of this 
chapter.
    (c) Conditions of use. (1) The drug is used for the treatment of 
canine otitis externa associated with yeast (Malassezia pachydermatis, 
formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.
    (2) For 7.5 or 15 g tube, instill 4 drops of ointment twice daily 
into the ear canal of dogs weighing less than 30 pounds, instill 8 drops 
twice daily for dogs weighing 30 pounds or more. For 215 g bottle, 
instill 2 drops of ointment twice daily into the ear canal of dogs 
weighing less than 30 pounds, instill 4 drops twice daily for dogs 
weighing 30 pounds or more. Therapy should continue for 7 consecutive 
days.
    (3) The external ear should be cleaned and dried before treatment. 
Remove foreign material, debris, crusted exudates, etc., with suitable 
solutions. Excessive hair should be clipped from the treatment area. If 
hypersensitivity occurs, treatment should be discontinued and alternate 
therapy instituted.
    (4) Corticosteroids administered to dogs, rabbits, and rodents 
during pregnancy have resulted in cleft palate in offspring. Other 
congenital anomalies including deformed forelegs, phocomelia, and 
anasarca have been reported in offspring of dogs which received 
corticosteroids during pregnancy. Clinical and experimental data have 
demonstrated that corticosteroids administered orally or parenterally to 
animals may induce the first stage of parturition if used during the 
last trimester of pregnancy and may precipitate premature parturition 
followed by dystocia, fetal death, retained placenta, and metritis.
    (5) 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]