Label: SYSTANE BALANCE- propylene glycol emulsion
- NDC Code(s): 0065-1433-02, 0065-1433-07, 0065-1433-11
- Packager: Alcon Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated November 26, 2021
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- SPL UNCLASSIFIED SECTION
- Drug Facts
- ACTIVE INGREDIENT
- Uses
-
Warnings
For external use only
When using this product
- do not touch tip of container to any surface to avoid contamination
- replace cap after each use
- Directions
- Other information
- Inactive ingredients:
- Questions:
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PRINCIPAL DISPLAY PANEL
Systane® BALANCE
Lubricant Eye Drops
Restorative Formula
CLINICAL STRENGTH
INTENSIVE THERAPY
Alcon®
STERILE
10 mL (1/3 FL OZ)SIDE PANEL
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.
ACTUAL SIZE.
U.S. Pat: www.alconpatents.com
©2016 Novartis
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.
Based on a survey of eye care professionals. Data on file.
Alcon
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134 USA
Printed in USA
9013179-0516 -
INGREDIENTS AND APPEARANCE
SYSTANE BALANCE
propylene glycol emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0065-1433 Route of Administration OPHTHALMIC 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) Polidronium Chloride (UNII: 6716Z5YR3G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0065-1433-02 1 in 1 CARTON 07/27/2010 1 10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 2 NDC:0065-1433-07 2 in 1 CARTON 07/27/2010 2 10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 3 NDC:0065-1433-11 1 in 1 CARTON 07/27/2010 3 1.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 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 Research LLC 007672236 manufacture(0065-1433)