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 23, 2020

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  • SPL UNCLASSIFIED SECTION

  • Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientPurpose
    Propylene Glycol 0.6%Lubricant
  • Uses

    • for the temporary relief of burning and irritation due to dryness of the eye
    • for use as a lubricant to prevent further irritation or to relieve dryness of the eye
  • 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

    • shake well before using
    • put 1 or 2 drops in the affected eye(s) as needed
  • Other information

    • store at room temperature
  • 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

  • SPL UNCLASSIFIED SECTION

  • PRINCIPAL DISPLAY PANEL

    TWIN PACK

    Systane    ®
    LUBRICANT EYE DROPS

    BALANCE
    RESTORING DRY EYE RELIEF

    Locks in moisture
    Tear evaporation protection
    Clinically proven

    #1 DOCTOR RECOMMENDED BRAND1
    STERILE
    Two 10mL (1/3 FL OZ) Bottles

    Alcon

    Systane Balance Twin Pack Carton Label

    Systane®BALANCE
    Lubricant Eye Drops

    Restorative Formula

    CLINICAL STRENGTH
    INTENSIVE THERAPY

    Alcon®
    STERILE
    10 mL (1/3 FL OZ)

    Systane Balance Carton Label

     

  • INGREDIENTS AND APPEARANCE
    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)
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