INDICATIONS AND USAGE
Neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone acetate ophthalmic ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye (see CLINICAL PHARMACOLOGY: Microbiology). The particular anti-infective drugs in this product are active against the following common bacterial eye pathogens: Staphylococcus aureus, streptococci, including Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. The product does not provide adequate coverage against Serratia marcescens.
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HOW SUPPLIED
Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate Ophthalmic Ointment is supplied in 3.5 g (1/8 Oz) sterile tamper proof tube with ophthalmic tip,
NDC 0168-0029-38.
Store at 15° to 25°C (59° to 77°F).
E. FOUGERA & CO.
a division of Altana Inc.
MELVILLE, NEW YORK 11747
I22938E
R8/04
#174
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