[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: 21CFR524.981d]

[Page 300]
 
                        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.  524.981d  Fluocinolone acetonide, dimethyl sulfoxide solution.

    (a) Specifications. Each milliliter of solution contains 0.01 
percent fluocinolone acetonide and 20 percent dimethyl sulfoxide with 
propylene glycol and citric acid.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used in dogs for the relief 
of impaction commonly present in apparently normal anal sacs, for the 
reversal of inflammatory changes associated with abnormal anal sacs, and 
to counteract the offensive odor of anal sac secretions.
    (2) It is administered by instillation of 1 to 2 milliliters into 
each anal sac following expression of anal sac contents. It may be 
necessary to repeat treatment at 60-day intervals to maintain an odor-
free state. The total dosage used should not exceed 2 milliliters per 
anal sac per treatment.
    (3) For use only by or on the order of a licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 61 FR 5507, Feb. 13, 1996]