Label: SYSTANE DAY AND NIGHT VALUE PACK- polyethylene glycol 400, propylene glycol 0.3% kit

  • NDC Code(s): 0065-1502-10
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2023

If you are a consumer or patient please visit this version.

  • SYSTANE® ULTRA Lubricant Eye Drops

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

    • temporary relief of burning and irritation due to dryness of the eye
    • temporarily relieves 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

    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® (polyquaternium-1) 0.001% preservative, 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

  • SYSTANE® GEL DROPS Lubricant Eye Gel

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

    • temporary relief of burning and irritation due to dryness of the eye
    • temporarily relieves 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

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

  • Questions?

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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    DAY & NIGHT VALUE PACK

    Systane®

    ULTRA
    LUBRICANT EYE DROPS

    HIGH PERFORMING DRY EYE RELIEF

    DAYTIME

    Fast-acting hydration and lasting relief
    Moisture-rich formula

    #1 DOCTOR RECOMMENDED BRAND1

    GEL DROPS
    LUBRICANT EYE GEL

    SOOTHING DRY EYE RELIEF

    NIGHTTIME

    Long-lasting formula
    Day or night protection

    LIQUID GEL

    STERILE

    Two 10 mL Bottles (1/3 FL OZ EACH)

    Alcon®

    This Value Pack
    gives you fast-acting
    hydration and
    long-lasting relief,
    for day or night
    protection.

    ACTUAL SIZE BOTTLES

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

    www.alconpatents.com

    ALCON LABORATORIES, INC.
    Fort Worth, TX 76134 USA 

    Made in USA from domestic and
    foreign materials

    300048647-0621
     
    LOT:
    EXP.:

    Carton

    Systane® ULTRA
    LUBRICANT EYE DROPS

    HIGH PERFORMANCE

    STERILE
    10 mL (1/3 FL OZ)

    FOR EXTERNAL USE ONLY.

    INDICATIONS:
    For the temporary relief of burning and irritation due to dryness of the eye.

    DIRECTIONS:
    Shake well and instill 1 or 2 drops in the affected eye(s) as needed.

    WARNINGS:
    See carton for WARNINGS.

    INGREDIENTS:

    Actives:
    Polyethylene Glycol 400 0.4%, Propylene Glycol 0.3%.

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

    Store at room temperature. 

    Alcon Laboratories, Inc.
    Fort Worth, TX 76134 USA

    Alcon®

    LOT:

    EXP.:

    300055616-1221

    Ultra DayNight bottle label

    Systane®GEL DROPS
    LUBRICANT EYE GEL

    Soothing Dry Eye Relief

    STERILE
    10 mL (1/3 FL OZ)

    FOR EXTERNAL USE ONLY.

    Uses: See carton for USES.

    WARNINGS:
    See carton for WARNINGS.

    Directions: Shake well and put 1 or 2 drops in the affected eye(s) as needed.  

    INGREDIENTS:

    Actives: Polyethylene Glycol 0.4% and Propylene Glycol 0.3%.

    Inactives: Aminomethylpropanol, boric acid, edetate disodium, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, sorbitol and purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.
    Store at room temperature. 

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

    LOT:
    EXP.:

    300048641-0621

    Bottle Label
  • INGREDIENTS AND APPEARANCE
    SYSTANE DAY AND NIGHT VALUE PACK 
    polyethylene glycol 400, propylene glycol 0.3% kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-1502
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-1502-101 in 1 CARTON; Type 0: Not a Combination Product10/24/201704/30/2024
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 10 mL
    Part 21 BOTTLE 10 mL
    Part 1 of 2
    SYSTANE ULTRA LUBRICANT EYE DROPS 
    polyethylene glycol 400, propylene glycol solution
    Product Information
    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)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    110 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01810/24/2017
    Part 2 of 2
    SYSTANE DROPS 
    polyethylene glycol 400, propylene glycol solution
    Product Information
    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)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Guar Gum (UNII: E89I1637KE)  
    Polidronium Chloride (UNII: 6716Z5YR3G)  
    Potassium Chloride (UNII: 660YQ98I10)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sorbitol (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    110 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01810/24/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01810/24/2017
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Research LLC007672236manufacture(0065-1502)