SYSTANE DAY AND NIGHT VALUE PACK (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL 0.3%) KIT [ALCON LABORATORIES, INC.]

SYSTANE DAY AND NIGHT VALUE PACK (POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL 0.3%) KIT [ALCON LABORATORIES, INC.]
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NDC 0065-1502-10
Set ID df13ca6f-7ce1-455a-ae13-9bbc5e9d2e07
Category HUMAN OTC DRUG LABEL
Packager Alcon Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART349
  • 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

    © 2018 Novartis

    ALCON LABORATORIES, INC.
    Fort Worth, TX 76134 USA 

    Made in USA from domestic and foreign materials

    9015877-0218
     
    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.:

    H14351-0516

    DayNight Ultra Bottle Label

    Systane®GEL DROPS
    LUBRICANT EYE DROPS

    ANYTIME PROTECTION

    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 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.
    6201 South Freeway,
    Fort Worth, TX 76134 USA
    ©2010, 2013 Novartis

    Alcon®

    LOT:

    EXP.:

    H14343-0416

    DayNight Gel Drop 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 Product10/24/2017
    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 finalpart34910/24/2017
    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 finalpart34910/24/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34910/24/2017
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Research LLC007672236manufacture(0065-1502)

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