Label: SYSTANE COMPLETE PF- propylene glycol emulsion

  • NDC Code(s): 0065-1530-01
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 3, 2023

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  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Propylene Glycol 0.6%Lubricant

  • Uses

    • for the temporary relief of burning and irritation due to dryness of the eye
    • for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
    • for use as a protectant against further irritation or to relieve 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 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

    • 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, hydroxypropyl guar, mineral oil, polyoxyl 40 stearate, 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
    alcon.medinfo@alcon.com

    Alcon Laboratories, Inc.
    Fort Worth, TX 76134 USA
    Made in France
    www.alconpatents.com

    NDC: 0065-1530-01

    437600

  • PRINCIPAL DISPLAY PANEL

    SAMPLE-NOT FOR SALE

    Systane®
    LUBRICANT EYE DROP

    COMPLETE PF

    PRESERVATIVE-FREE
    DRY EYE RELIEF

    Fast-acting hydration for sensitive eyes

    Tear evaporation protection

    Nano-droplets for better coverage*

    Only available at retail in a preservative-free bottle

    #1 DOCTOR RECOMMENDED BRAND1

    Alcon

    STERILE
    5 Vials 0.5 mL (0.01 FL OZ) each

    Side Panel:

    Exclusive Formula Not Sold in Store Brands

    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.

    TAMPER EVIDENT: For your protection, do not use if vial is damaged or opened.

    437600

    1Based on a survey of eye care professionals.

    Data on file.   

     *vs SYSTANE® BALANCE

    LOT :
    EXP:

    2737

    Systane COMPLETE PF
  • INGREDIENTS AND APPEARANCE
    SYSTANE COMPLETE PF 
    propylene glycol emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-1530
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Propylene Glycol (UNII: 6DC9Q167V3) (Propylene Glycol - UNII:6DC9Q167V3) Propylene Glycol.06 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Boric Acid (UNII: R57ZHV85D4)  
    Dimyristoylphosphatidylglycerol, Dl- (UNII: BI71WT9P3R)  
    Guaraprolose (3500 Mpa.S At 1%) (UNII: 3A1I7376TC)  
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-1530-015 in 1 CARTON02/01/2022
    10.5 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01802/01/2022
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kaysersberg Pharmaceuticals267486052manufacture(0065-1530)
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