[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: 21CFR524.981b]

[Page 301-302]
 
                        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. 524.981b  Fluocinolone acetonide solution.

    (a) Specifications. The drug contains 0.01 percent fluocinolone 
acetonide in propylene glycol with citric acid.
    (b) Sponsor. See No. 099207 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is indicated for the relief of 
pruritus and inflammation associated with otitis

[[Page 302]]

externa and certain superficial acute and chronic dermatoses in the dog. 
It is also indicated for the relief of pruritus and inflammation 
associated with acute otitis externa and certain superficial acute and 
chronic dermatoses in the cat.
    (2) A small amount of solution is applied to the affected area 2 or 
3 times daily.
    (3) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[40 FR 13873, Mar. 27, 1975, as amended at 62 FR 40932, July 31, 1997]