Statrol Ophthalmic Solution

Name: Statrol Ophthalmic Solution

Clinical pharmacology

The anti-infective components in Statrol Ophthalmic Solution provide action against specific organisms susceptible to them. Polymyxin B Sulfate and Neomycin Sulfate are active in vitro against Staphylococcus aureus, Escherichia coli, Klebsiella/Enterobacter species, Neisseria species, Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescens, Streptococci, including Streptococcus pneumoniae.

Contraindications

Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication.

Adverse reactions

Adverse reactions have occurred with the anti-infective components. Exact incidence figures are not available since no denominator of treated patients is available. Reactions occurring most often from the presence of the anti-infective ingredients are allergic sensitizations. (SEE WARNINGS.)

How supplied

STATROL (Neomycin and Polymyxin B Sulfates Ophthalmic Solution, USP) in 5 mL plastic DROP-TAINER® dispenser: NDC 0998-0623-05.

STORAGE: Store at 46° - 80°F (8° - 27°C).

Federal (USA) law prohibits dispensing without prescription.

Alcon®
OPHTHALMIC
ALCON (Puerto Rico) INC.
Humacao, Puerto Rico 00791 USA

Revised: June 1995 
Printed in USA
238382

STATROL 
neomycin sulfate and polymyxin b sulfate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0998-0623
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
neomycin sulfate (neomycin) neomycin 3.5 mg  in 1 mL
polymyxin B sulfate (polymyxin B) polymyxin B 16250   in 1 mL
Inactive Ingredients
Ingredient Name Strength
benzalkonium chloride  
hydroxypropyl methylcellulose 2910  
boric acid  
sodium chloride  
hydrochloric acid  
sodium hydroxide  
water  
Packaging
# Item Code Package Description
1 NDC:0998-0623-05 5 mL (5 MILLILITER) in 1 BOTTLE, PLASTIC
STATROL 
neomycin sulfate and polymyxin b sulfate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0065-0623
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
neomycin sulfate (neomycin) neomycin 3.5 mg  in 1 mL
polymyxin B sulfate (polymyxin B) polymyxin B 16250   in 1 mL
Inactive Ingredients
Ingredient Name Strength
benzalkonium chloride  
hydroxypropyl methylcellulose 2910  
boric acid  
sodium chloride  
hydrochloric acid  
sodium hydroxide  
water  
Packaging
# Item Code Package Description
1 NDC:0065-0623-05 5 mL (5 MILLILITER) in 1 BOTTLE, PLASTIC
Labeler - Alcon
Revised: 05/2006   Alcon
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