[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: 21CFR524.1204]

[Page 307-308]
 
                        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. 524.1204  Kanamycin sulfate, calcium amphomycin, and hydrocortisone 
acetate.

    (a) Specifications. (1) Calcium amphomycin is the calcium salt of 
amphomycin. It conforms to the following specifications:
    (i) Its potency is not less than 863 micrograms of amphomycin per 
milligram;
    (ii) Its moisture content is not more than 10 percent; and
    (iii) Its pH in a 2-percent aqueous suspension is 6.0 to 7.5.
    (2) The drug is in a water-miscible ointment or cream base and each 
gram of ointment or cream contains: 5.0 milligrams of kanamycin activity 
as the sulfate, 5.0 milligrams of amphomycin activity as the calcium 
salt, and 10.0 milligrams of hydrocortisone acetate.
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) It is indicated for use in dogs in the 
following conditions associated with bacterial infections caused by 
organisms susceptible to one or both antibiotics: Acute otitis externa, 
furunculosis, folliculitis, pruritus, anal gland infections, erythema, 
decubital ulcer, superficial wounds, and superficial abscesses.

[[Page 308]]

    (2) The ointment should be applied to the affected areas of the skin 
at least twice daily. In severe or widespread lesions it may be 
desirable to apply the ointment more than twice daily. After some 
improvement is observed, treatment can usually be reduced to once daily. 
Before application, hair in the affected area should be closely clipped 
and the area should be thoroughly cleansed of crusts, scales, dirt, or 
other detritus. When treating infections of the anal gland, the drug 
should be introduced into the orifice of the gland and not through any 
fistulous tract. If no response is evident in 7 days, diagnosis and 
therapy should be reevaluated.
    (3) For use only by or on the order of a licensed veterinarian.

[40 FR 13858, Mar. 27, 1975, as amended at 53 FR 12512, Apr. 15, 1988; 
53 FR 27851, July 25, 1988; 64 FR 404, Jan. 5, 1999]