[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: 21CFR524.981e]

[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. 524.981e  Fluocinolone acetonide, dimethyl sulfoxide otic solution.

    (a) Specifications. Each milliliter of solution contains 0.01 
percent of fluocinolone acetonide in 60 percent dimethyl sulfoxide with 
propylene glycol and citric acid.
    (b) Sponsor. See No. 000033 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used in dogs for the relief 
of pruritis and inflammation associated with acute and chronic otitis.
    (2) It is administered at 4 to 6 drops (0.2 milliliter) twice daily 
into the ear canal for a maximum period of 14 days. The total dosage 
used should not exceed 17 milliliters. The ear canal should be cleansed 
by some appropriate method prior to instillation of the solution and the 
ear should be massaged gently following instillation.
    (3) There should be careful initial evaluation and followup of 
infected ears. Incomplete response or exacerbation of corticosteroid-
responsive lesions may be due to the presence of an infection which 
requires identification or antibiotic sensitivity testing, and the use 
of the appropriate antimicrobial agent. As with any corticosteroid, 
animals with a generalized infection should not be treated with this 
product without proper supportive antimicrobial therapy. Preparations 
with dimethyl sulfoxide should not be used in pregnant animals. For use 
by or on the order of a licensed veterinarian.