[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: 21CFR524.1044e]

[Page 304-305]
 
                        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. 524.1044e  Gentamicin sulfate spray.

    (a) Specification. Each milliliter of sterile aqueous solution 
contains gentamicin sulfate equivalent to 1.07 milligrams of gentamicin.
    (b) Sponsor. See No. 000061 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use. (1) The drug is indicated for the treatment 
of pink eye in cattle (infectious bovine keratoconjunctivitis) caused by 
Moraxella bovis.
    (2) One actuation of the sprayer delivers 0.7 milliliter containing 
0.75 milligram gentamicin. The sprayer should be held upright 3 to 6 
inches from the

[[Page 305]]

affected eye, with the opening directed towards the eye, and pumped 
once. It is advisable to treat once a day for up to 3 days.
    (3) Conditions other than bacterial infections of the bovine eye and 
infectious keratoconjunctivitis caused by Moraxella bovis may produce 
similar signs. If conditions persists or increases, discontinue use and 
consult veterinarian.

[48 FR 41157, Sept. 14, 1983, as amended 52 FR 7833, Mar. 13, 1987]