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

Drug Facts

Active IngredientPurpose
Propylene Glycol 0.6%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 experience any of the following:

  • eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • condition worsens or persists for 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
alcon.medinfo@alcon.com
www.systane.com

PRINCIPAL DISPLAY PANEL

Systane®
LUBRICANT EYE DROPS 

BALANCE

Restoring
Dry Eye Relief


Locks in moisture
Tear evaporation protection
Clinically proven  

DOCTOR RECOMMENDED #1 BRAND1

Alcon
STERILE

10 mL (1/3 FL OZ)

LOT:                                         EXP.:

SIDE PANEL

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.

www.alconpatents.com

Made in USA from domestic and
imported materials

Systane®
BALANCE
Lubricant
Eye
Drops
restores the
natural tear’s
lipid layer to
lock in moisture
and protect
against tear
evaporation.


ACTUAL SIZE

Alcon
Alcon Laboratories, Inc.
Fort Worth, TX 76134 USA

1 Based on a survey of eye care
professionals. Data on file.    

300048644-0521


Systane Balance Carton Label

 

SYSTANE BALANCE  
propylene glycol emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-1433
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Propylene Glycol (UNII: 6DC9Q167V3) (Propylene Glycol - UNII:6DC9Q167V3) Propylene Glycol0.06 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0065-1433-021 in 1 CARTON07/27/2010
110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2NDC:0065-1433-072 in 1 CARTON07/27/2010
210 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3NDC:0065-1433-111 in 1 CARTON07/27/2010
31.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34907/27/2010
Labeler - Alcon Laboratories, Inc. (008018525)
Establishment
NameAddressID/FEIBusiness Operations
Alcon Research LLC007672236manufacture(0065-1433)

Revised: 6/2022
Document Id: bd53f321-290c-43ed-99f5-ceb1fda201b8
Set id: c7b1a03a-a5f2-409e-a34a-d6f166671de5
Version: 8
Effective Time: 20220622
 
Alcon Laboratories, Inc.