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

  • NDC Code(s): 0065-1431-01, 0065-1431-05, 0065-1431-18, 0065-1431-21, view more
    0065-1431-28, 0065-1431-31, 0065-1431-41, 0065-1431-80
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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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 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 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

    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

    aminomethylpropanol, boric acid, hydroxypropyl guar, POLYQUAD® (polyquarternium-1) 0.001% preservative, potassium chloride, purified water, sodium chloride, sorbitol. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • ACTIVE INGREDIENT

  • ACTIVE INGREDIENT

  • PURPOSE

  • STOP USE

  • KEEP OUT OF REACH OF CHILDREN

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    Systane®
    LUBRICANT EYE DROPS

    ULTRA
    HIGH PERFORMING
    DRY EYE RELIEF

    Fast-acting hydration
    and lasting relief
    Moisture rich formula

    #1 Doctor Recommended Brand1

    Alcon STERILE 
    10mL (1/3 FL OZ)  

    SIDE PANEL: 

    TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase.

    www.alconpatents.com
    Country of Origin Singapore

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

    From first blink, eyes feel lubricated and refreshed. Feel the difference in dry eye relief with SYSTANE® ULTRA.

    ACTUAL SIZE  

    Alcon
    Alcon Laboratories, Inc.
    Fort Worth, TX 76134 USA

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

    300051205-0122

    300051205-0122

    Systane®
    LUBRICANT EYE DROPS

    ULTRA
    HIGH PERFORMING
    DRY EYE RELIEF

    Fast-acting hydration
    and lasting relief
    Moisture rich formula

    #1 Doctor Recommended Brand1Alcon STERILE 
    10mL (1/3 FL OZ)  

    SIDE PANEL:

    TAMPER EVIDENT: For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase.

    www.alconpatents.com
    Made in USA from domestic and imported materials.

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

    From first blink, eyes feel lubricated and refreshed.

    Feel the difference in dry eye relief with SYSTANE® ULTRA.

    ACTUAL SIZE  

    Alcon
    Alcon Laboratories, Inc.
    Fort Worth, TX 76134 USA

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

    300051246-1221

    300051246-1221
  • INGREDIENTS AND APPEARANCE
    SYSTANE ULTRA 
    polyethylene glycol 400 and propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-1431
    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)  
    Guar Gum (UNII: E89I1637KE)  
    Polidronium Chloride (UNII: 6716Z5YR3G)  
    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:0065-1431-801 in 1 CARTON10/01/2014
    13 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:0065-1431-011 in 1 CARTON10/01/2014
    21.5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    3NDC:0065-1431-051 in 1 CARTON10/01/2014
    310 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    4NDC:0065-1431-183 in 1 CARTON10/01/2014
    410 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    5NDC:0065-1431-211 in 1 CARTON10/01/2014
    53 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    6NDC:0065-1431-282 in 1 CARTON10/01/2014
    64 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    7NDC:0065-1431-311 in 1 CARTON10/01/2014
    74 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    8NDC:0065-1431-412 in 1 CARTON10/01/2014
    810 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 DrugM01810/01/2014
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Research LLC007672236manufacture(0065-1431)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Singapore Manufacturing Pte Ltd595170137manufacture(0065-1431)
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