SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]

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  • SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]

SYSTANE ULTRA (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON LABORATORIES, INC.]
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NDC 0065-1432-01, 0065-1432-02, 0065-1432-03, 0065-1432-04, 0065-1432-05, 0065-1432-06
Set ID a5c1c194-3db5-4f18-9cd1-97f7f84c3cff
Category HUMAN OTC DRUG LABEL
Packager Alcon Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART349
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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
  • 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 feel eye pain
    • changes in vision occur
    • redness or irritation of the eye(s) gets worse, persists or lasts more than 72 hours

    Keep out of reach of children.
    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Instill 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

    CONVENIENT PRESERVATIVE-FREE VIALS

    #1 Doctor Recommended Brand1
    Systane    ® ULTRA
    LUBRICANT EYE DROPS    

    HIGH PERFORMANCE

    EXTENDED PROTECTION
    FAST SYMPTOM RELIEF
    PRESERVATIVE-FREE VIALS  

    STERILE
    60 Vials 0.7 mL Each  

    Alcon®
    A Novartis company

    Carton
    Carton
  • 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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