[Code of Federal Regulations]
[Title 21, Volume 6]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR524.960]

[Page 297-298]
 
                        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. 524.960  Flumethasone, neomycin sulfate, and polymyxin B sulfate ophthalmic solutions.

    (a) Specifications. Each milliliter of ophthalmic preparation 
contains 0.10 milligram flumethasone, 5.0 milligrams neomycin sulfate 
(3.5 milligrams neomycin base), and 10,000 units of polymyxin B sulfate, 
with or without hydroxypropyl methylcellulose.
    (b) Sponsor. See No. 000856 in Sec. 510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount--(i) Preparation containing 
hydroxypropyl methylcellulose. Dogs: 1 to 2 drops per eye, every 6 
hours.
    (ii) Preparation without hydroxyproply methylcellulose. Dogs and 
cats: 2 to 3 drops per eye, every 4 hours.
    (2) Indications for use. Treatment of the inflammation, edema, and 
secondary bacterial infections associated with topical ophthalmological 
conditions of the eye such as corneal injuries, incipient pannus, 
superficial keratitis, conjunctivitis, acute nongranulomatous anterior 
uveitis, kerato- conjunctivitis, and blepharitis.
    (3) Limitations. (i) In treating ophthalmological conditions 
associated with bacterial infections, the drug is contraindicated in 
those cases in which microorganisms are not susceptible to the 
antibiotics incorporated in the drug.
    (ii) The drug is contraindicated in infectious tuberculous lesions 
of the eye, early acute stages of viral diseases of the cornea and 
conjunctiva, herpes simplex lesions of the eye, and fungal infections of 
the conjunctiva and eyelids.
    (iii) The usual precautions and contraindications for 
corticosteroids and

[[Page 298]]

adrenocorticoids are applicable with this drug. Corticosteroids may 
inhibit essential inflammatory responses intrinsic to the fundamental 
healing mechanism. Adrenocorticoid compounds have been reported to cause 
an increase in intraocular pressure. Intraocular pressure should be 
checked frequently. Ocular reexaminations should be made at frequent 
intervals during long-term therapy.
    (iv) Federal law restricts this drug to use by or on the order of a 
licensed veterinarian.

[44 FR 16012, Mar. 16, 1979, as amended at 61 FR 5507, Feb. 13, 1996]