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

  • NDC Code(s): 0065-1432-01, 0065-1432-02, 0065-1432-03, 0065-1432-04, view more
    0065-1432-05, 0065-1432-06
  • 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 December 22, 2022

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  • ACTIVE INGREDIENT

    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
    • for temporary relief of discomfort due to minor irritation 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 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

    • Put 1 or 2 drops in the affected eye(s) as needed.
  • 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
    www.systane.com

  • PRINCIPAL DISPLAY PANEL

    Systane®
    LUBRICANT EYE DROPS    

    ULTRA PF

    PRESERVATIVE-FREE
    DRY EYE RELIEF

    Convenient Single Vials On-The-Go

    Great for sensitive eyes

    Fast-acting hydration
    and lasting relief

    Moisture-rich formula

    #1 Doctor Recommended Brand1

    STERILE
    60 Vials 0.7 mL Each

    Alcon

    SIDE DISPLAY PANEL

    Systane®
    LUBRICANT EYE DROPS

    ULTRA PF

    PRESERVATIVE-FREE
    DRY EYE RELIEF

    Convenient Single Vials On-The-Go

    Open your eyes to a
    breakthrough in comfort with
    SYSTANE® ULTRA Lubricant Eye Drops.

    SYSTANE®ULTRA preservative-free vials
    elevates the science of dry eye therapy
    to a new level so you can have relief
    from dry eye anytime, anywhere.

    From first blink eyes feel lubricated
    and refreshed.

    Feel the difference in dry eye relief
    with SYSTANE® ULTRA

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

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

    www.alconpatents.com
    Made in France

    W435221-0919

    Carton Label
  • INGREDIENTS AND APPEARANCE
    SYSTANE  ULTRA
    polyethylene glycol 400 and propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-1432
    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
    Aminomethylpropanol (UNII: LU49E6626Q)  
    BORIC ACID (UNII: R57ZHV85D4)  
    GUAR GUM (UNII: E89I1637KE)  
    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:0065-1432-0124 in 1 CARTON07/27/200912/31/2017
    10.4 mL in 1 VIAL; Type 0: Not a Combination Product
    2NDC:0065-1432-024 in 1 CARTON07/27/200912/31/2017
    20.4 mL in 1 VIAL; Type 0: Not a Combination Product
    3NDC:0065-1432-0372 in 1 CARTON07/27/200912/31/2017
    30.4 mL in 1 VIAL; Type 0: Not a Combination Product
    4NDC:0065-1432-045 in 1 CARTON07/27/2009
    4.7 mL in 1 VIAL; Type 0: Not a Combination Product
    5NDC:0065-1432-0560 in 1 CARTON07/27/2009
    5.7 mL in 1 VIAL; Type 0: Not a Combination Product
    6NDC:0065-1432-0625 in 1 CARTON07/27/2009
    6.7 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34907/27/2009
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kaysersberg Pharmaceuticals267486052manufacture(0065-1432)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratoire Unither574139809manufacture(0065-1432)
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