[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: 21CFR524.1200b]

[Page 305-306]
 
                        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.  524.1200b  Kanamycin ophthalmic aqueous solution.

    (a) Specifications. The drug, which is in an aqueous solution 
including suitable and harmless preservatives and buffer substances, 
contains 10 milligrams of kanamycin activity (as the sulfate) per 
milliliter of solution.
    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use. It is indicated for use in dogs in various 
eye infections due to kanamycin sensitive bacteria. It is used in 
treating conditions such as conjunctivities, blepharitis, 
dacryocystitis, keratitis, and corneal ulcerations and as a prophylactic 
in traumatic conditions, removal of foreign bodies, and intraocular 
surgery. Instill a few drops into the affected eye every 3 hours or more 
frequently if deemed advisable. Administer as frequently as possible for 
the first 48

[[Page 306]]

hours, after which the frequency of applications may be decreased. 
Treatment should be continued for at least 48 hours after the eye 
appears normal. For use only by or on the order of a licensed 
veterinarian.

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