[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: 21CFR524.1443]

[Page 307]
 
                        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.  524.1443  Miconazole nitrate cream; miconazole nitrate lotion; miconazole nitrate spray.

    (a) Specifications. (1) The cream contains 23 milligrams of 
miconazole nitrate (equivalent to 20 milligrams of miconazole base) per 
gram.
    (2) The lotion contains 1.15 percent of miconazole nitrate 
(equivalent to 1 percent miconazole base).
    (3) The spray product consists of a dispensing container, sprayer 
pump assembly, and lotion which contains 1.15 percent of miconazole 
nitrate (equivalent to 1-percent miconazole base).
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter for 
use of cream, lotion, and spray; see No. 051259 in Sec.  510.600(c) of 
this chapter for use of lotion and spray.
    (c) Conditions of use. (1) Miconazole nitrate is an antifungal agent 
for topical treatment of infections in dogs and cats caused by 
Microsporum canis, Microsporum gypseum, and Trichophyton mentagrophytes.
    (2) Apply once daily by rubbing into or spraying a light covering on 
the infected site and the immediate surrounding vicinity. Continue 
treatment for 2 to 4 weeks until infection is completely eradicated as 
determined by appropriate laboratory examination.
    (3) Accurate diagnosis of infecting organism is essential. Identify 
by microscopic examination of a mounting of infected tissue in potassium 
hydroxide solution or by culture on an appropriate medium.
    (4) If no improvement is observed in 2 weeks, reevaluate diagnosis 
and therapy.
    (5) Avoid contact with eyes since irritation may result.
    (6) 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 53 FR 26242, July 12, 1988; 
62 FR 55161, Oct. 23, 1997; 62 FR 61626, Nov. 19, 1997]