Label: SYSTANE- polyethylene glycol and propylene glycol solution/ drops

  • NDC Code(s): 0065-0431-04, 0065-0431-32, 0065-0431-33, 0065-0431-57
  • Packager: Alcon Research Ltd
  • 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 June 30, 2022

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  • Active Ingredients

  • PURPOSE

    Active IngredientsPurpose
    Polyethylene Glycol 400 0.4%Lubricant
    Propylene Glycol 0.3%Lubricant
  • Uses

    • For the temporary relief of burning and irritation due to dryness of the eye
  • Warnings

    For external use only

    Do not use

    • if this product changes color or becomes cloudy
    • 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
    • do not reuse
    • once opened, discard

    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

    • instill 1 or 2 drops in the affected eye(s) as needed
  • Other Information

    • store at room temperature
    • protect from light
  • Inactive Ingredients

    boric acid, calcium chloride, hydroxypropyl guar, magnesium chloride, potassium chloride, purified water, sodium chloride, zinc chloride.  May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • Questions?

    In the U.S. call 1-800-757-9195
    www.systane.com

  • Principal Display Panel

    CONVENIENT PRESERVATIVE-FREE VIALS

    #1 Doctor Recommended Brand1
    Systane    ®
    LUBRICANT EYE DROPS    

    PRESERVATIVE-FREE VIALS

    LONG LASTING RELIEF
    SOOTHING COMFORT
    DRY EYE THERAPY  

    STERILE
    30 Vials 0.7 mL Each  

    Alcon®
    a Novartis company

    Carton

    Principal Display Panel

    Systane®
    LUBRICANT EYE DROPS    

    ORIGINAL PF
    PRESERVATIVE-FREE
    DRY EYE RELIEF

    Convenient
    Single Vials
    On-the-Go

    Great for Sensitive Eyes
    Refreshes & Lubricates
    Soothing Comfort

    #1 Doctor Recommended Brand1

    STERILE
    30     Vials 0.7 mL Each

    Alcon

    Side Panel (s)

    SOOTHING COMFORT
    SYSTANE® Original PF
    Lubricant Eye Drops is scientifically
    formulated to shield eyes from
    dry eye discomfort so that
    eyes feel refreshed.  

    LONG-LASTING RELIEF
    SYSTANE® Original PF
    Lubricant Eye Drops provides
    long-lasting dry eye relief.  

    PRESERVATIVE-FREE
    SYSTANE® Original PF
    Lubricant Eye Drops comes in
    convenient preservative-free vials
    so you can enjoy relief from dry
    eye anytime, anywhere.  

    TAMPER EVIDENT: Do not use if vial is
    damaged or opened at time of purchase.

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

    www.alconpatents.com  

    Made in France

    435241-0819  

    Systane®
    LUBRICANT EYE DROPS  

    ORIGINAL PF
    PRESERVATIVE-FREE
    DRY EYE RELIEF

    DIRECTIONS:
    Make sure container
    is intact before use.
    To open, COMPLETELY TWIST
    OFF TAB.

    Do not pull off.

    Put 1 or 2 drops in the
    affected eye(s) as needed.

    Throw away container.
    Do not reuse.

    Manufactured for:
    ALCON
    Alcon Laboratories, Inc.
    Fort Worth, TX 76134 USA

    Front Label
    Back Label
  • INGREDIENTS AND APPEARANCE
    SYSTANE 
    polyethylene glycol and propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-0431
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol, Unspecified - UNII:3WJQ0SDW1A) Polyethylene Glycol 4004 mg  in 1 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    GUAR GUM (UNII: E89I1637KE)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-0431-044 in 1 CARTON10/30/201512/31/2017
    10.4 mL in 1 VIAL; Type 0: Not a Combination Product
    2NDC:0065-0431-3228 in 1 CARTON10/30/201512/31/2017
    20.4 mL in 1 VIAL; Type 0: Not a Combination Product
    3NDC:0065-0431-5740 in 1 CARTON10/30/201512/31/2017
    30.4 mL in 1 VIAL; Type 0: Not a Combination Product
    4NDC:0065-0431-3330 in 1 CARTON10/30/2015
    40.7 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34910/30/2015
    Labeler - Alcon Research Ltd (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kaysersberg Pharmaceuticals267486052manufacture(0065-0431)
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