[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: 21CFR529.400]

[Page 325-326]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS--Table of Contents
 
Sec.  529.400  Chlorhexidine tablets and suspension.

    (a) Specification. Each tablet and each 28-milliliter syringe of 
suspension contain 1 gram of chlorhexidine dihydrochloride.\1\
---------------------------------------------------------------------------

    \1\ These conditions are NAS/NRC reviewed and deemed effective. 
Applications for these uses need not include effectiveness data as 
specified by Sec.  514.111 of this chapter, but may require 
bioequivalency and safety information.
---------------------------------------------------------------------------

    (b) Sponsor. See No. 000856 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Place 1 or 2 tablets deep in each 
uterine horn; or infuse a solution of 1 tablet disolved in an 
appropriate amount of clean boiled water; or infuse one syringe of 
suspension into the uterus.\1\
    (2) Indications for use. For prevention or treatment of metritis and 
vaginitis in cows and mares when caused by

[[Page 326]]

pathogens sensitive to chlorhexidine dihydrochloride.\1\
    (3) Limitations. Prior to administration, remove any unattached 
placental membranes, any excess uterine fluid or debris, and carefully 
clean external genitalia. Use a clean, sterile inseminating pipette for 
administrating solutions and suspensions. Treatment may be repeated in 
48 to 72 hours.\1\

[43 FR 10705, Feb. 23, 1979]