[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: 21CFR524.981c]

[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. 524.981c  Fluocinolone acetonide, neomycin sulfate cream.

    (a) Specifications. The drug contains 0.025 percent fluocinolone 
acetonide and 0.5 percent neomycin sulfate (0.35 percent neomycin base).
    (b) Sponsor. See No. 099207 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is used in the relief of 
pruritus and inflammation associated with superficial acute and chronic 
dermatoses in dogs. It is used in the treatment of such conditions as 
allergic and acute moist dermatoses and nonspecific dermatoses in dogs. 
It is used in the treatment of wound infections in dogs and cats.
    (2) A small amount is applied to the infected area two or three 
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]