SYSTANE BALANCE- propylene glycol emulsion 
Alcon Laboratories, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SYSTANE® BALANCE Lubricant Eye Drops

Restorative Formula
Clinical Strength
Intensive Therapy

Alcon®
Sterile
10 mL (1/3 FL OZ)

Drug Facts

Active Ingredient

Propylene Glycol 0.6%

Purpose

Lubricant

Uses

Warnings

For external use only.

Do not use

  • if this product changes color
  • if you are sensitive to any ingredient in this product

When using this product

  • do not touch tip of container to any surface to avoid contamination
  • replace cap after each use

Stop use and ask a doctor if

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other Information

Inactive Ingredients:

Boric acid, dimyristoyl phosphatidylglycerol, edetate disodium, hydroxypropyl guar, mineral oil, polyoxyl 40 stearate, POLYQUAD® (polyquaternium-1) 0.001% preservative, sorbitan tristearate, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions:

In the U.S. call 1-800-757-9195

www.systane.com

MedInfo@AlconLabs.com


TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase.


Upgrade to a higher standard of relief. SYSTANE® BALANCE Lubricant Eye Drops has the proven power to restore the natural tear's lipid layer to treat dryness and provide long lasting relief.

U.S. Patent Nos. 5,278,151; 5,294,607; 5,578,586; 6,583,124; 6,838,449; 6,849,253

© 2010 Alcon, Inc.

Alcon®
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134 USA

Printed in USA

Principal Display Panel

Systane®
BALANCE

LUBRICANT EYE DROPS

Restorative Formula

CLINICAL STRENGTH
INTENSIVE THERAPY

Alcon®
STERILE
10 mL (1/3 FL OZ)


systane-balance-01

 

SYSTANE  BALANCE
propylene glycol emulsion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0065-1433
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL 0.06 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
BORIC ACID (UNII: R57ZHV85D4)  
DIMYRISTOYLPHOSPHATIDYLGLYCEROL, DL- (UNII: BI71WT9P3R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GUAR GUM (UNII: E89I1637KE)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
SORBITAN TRISTEARATE (UNII: 6LUM696811)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0065-1433-02 1 in 1 CARTON
1 10 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 07/27/2010
Labeler - Alcon Laboratories, Inc. (008018525)
Establishment
Name Address ID/FEI Business Operations
Alcon Laboratories, Inc. 008018525 MANUFACTURE

Revised: 9/2010
Document Id: c7b1a03a-a5f2-409e-a34a-d6f166671de5
Set id: c7b1a03a-a5f2-409e-a34a-d6f166671de5
Version: 1
Effective Time: 20100913
 
Alcon Laboratories, Inc.