Label: SYSTANE ULTRA PRESERVATIVE FREE- polyethylene glycol 400 and propylene glycol solution/ drops

  • NDC Code(s): 0065-1507-82, 0065-1507-92
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 15, 2023

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  • PURPOSE

    Active IngredientsPurpose
    Polyethylene Glycol 400 0.4%Lubricant
    Propylene Glycol 0.3%Lubricant
  • ACTIVE INGREDIENT

  • 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
  • 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 the product

    • do not touch tip of container to any surface to avoid contamination
    • replace cap after each use
  • STOP 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
    • see side of carton for directions for use
  • Other Information

    • Store at room temperature
  • Inactive ingredients

    Aminomethylpropanol, boric acid, hydroxypropyl guar, potassium chloride, purified water, sodium chloride, sorbitol. 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

  • Directions for Use:

    • Hold the bottle just below the cap and twist the cap to open.
    • BEFORE FIRST USE, hold the bottle upside down and dispense one drop of product to discard.
    • Shake the bottle downward to remove residual product (see picture).
    Use Diagram
    • Place 1 or 2 drops in the affected eye(s) as needed and blink.
    • After use, shake the bottle downward to remove residual product that may be left on the tip (see picture above).
    • Replace cap after use.
  • PRINCIPAL DISPLAY PANEL

    Preservative-Free

    Systane®
    LUBRICANT EYE DROPS
    ULTRA PF
    PRESERVATIVE-FREE
    DRY EYE RELIEF
    Fast-acting hydration and lasting relief
    Moisture rich formula for sensitive eyes
    Preservative-Free Bottle

    DOCTOR RECOMMENDED #1 Brand1

    STERILE
    10 mL (0.34 FL OZ)
    Alcon

    SIDE PANEL:
    TAMPER EVIDENT:
    For your protection, this bottle has a tamper evident ring around the bottom of the cap. Do not use if this ring is damaged or missing at the time of purchase.  

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

    300059081-1022

    Alcon Laboratories, Inc.
    Fort Worth, TX 76134 USA
    Country of Origin United States
    www.alconpatents.com

    Carton

    PRINCIPAL DISPLAY PANEL

    TWIN PACK

    Preservative-Free

    Systane®
    LUBRICANT EYE DROPS

    ULTRA PF
    PRESERVATIVE-FREE
    DRY EYE RELIEF

    Fast-acting hydration and lasting relief
    Moisture rich formula for sensitive eyes

    Preservative-Free Bottles

    DOCTOR RECOMMENDED #1 Brand1

    Alcon
    STERILE
    Two 10 mL (0.34 FL OZ) Bottles

    LOT:                                         EXP.:


    SIDE PANEL:

    TAMPER EVIDENT:
    For your protection, this bottle has a tamper evident ring around the bottom of the cap. Do not use if this ring is damaged or missing at the time of purchase.  

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


    Alcon Laboratories, Inc.
    Fort Worth, TX 76134 USA
    Country of Origin USA
    www.alconpatents.com

    ACTUAL SIZE

    300059122-1022

    Carton Label

    Systane®
    LUBRICANT EYE DROPS

    ULTRA PF
    PRESERVATIVE-FREE
    DRY EYE RELIEF

    STERILE
    10 mL (0.34 FL OZ)  

    Only for use in the eye.

    Store at room temperature.

    TAMPER EVIDENT: For your protection, this bottle has a tamper evident ring around the bottom of the cap. Do not use if this ring is damaged or missing at the time of purchase.  

    Alcon Laboratories, Inc.
    Fort Worth, TX 76134 USA

    See Carton for Directions For Use.  

    Country of Origin United States

    LOT:               EXP:

    300049451-0721

    Label
  • INGREDIENTS AND APPEARANCE
    SYSTANE ULTRA PRESERVATIVE FREE 
    polyethylene glycol 400 and propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-1507
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ) 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
    Aminomethylpropanol (UNII: LU49E6626Q)  
    Boric Acid (UNII: R57ZHV85D4)  
    Guaraprolose (3500 Mpa.S At 1%) (UNII: 3A1I7376TC)  
    Potassium Chloride (UNII: 660YQ98I10)  
    Water (UNII: 059QF0KO0R)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sorbitol (UNII: 506T60A25R)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-1507-821 in 1 CARTON02/15/2022
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:0065-1507-922 in 1 CARTON04/11/2023
    210 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 DrugM01802/15/2022
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Research LLC007672236manufacture(0065-1507)
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