SYSTANE (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON RESEARCH LTD]

SYSTANE (POLYETHYLENE GLYCOL AND PROPYLENE GLYCOL) SOLUTION/ DROPS [ALCON RESEARCH LTD]
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NDC 0065-0431-04, 0065-0431-32, 0065-0431-33, 0065-0431-57
Set ID 14916d2c-a63d-491e-bd91-a61f300af38a
Category HUMAN OTC DRUG LABEL
Packager Alcon Research Ltd
Generic Name
Product Class
Product Number
Application Number PART349
  • Active Ingredients

  • PURPOSE

    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 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

    • instill 1 or 2 drops in the affected eye(s) as needed
  • Other Information

    • store at room temperature
    • protect from light
  • Inactive Ingredients

    boric acid, calcium chloride, hydroxypropyl guar, magnesium chloride, potassium chloride, purified water, sodium chloride, zinc chloride.  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
    ®
    LUBRICANT EYE DROPS    

    PRESERVATIVE-FREE VIALS


    LONG LASTING RELIEF
    SOOTHING COMFORT
    DRY EYE THERAPY  

    STERILE
    30 Vials 0.7 mL Each  

    Alcon®

    a Novartis company

    Carton
  • INGREDIENTS AND APPEARANCE
    SYSTANE 
    polyethylene glycol and propylene glycol solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-0431
    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
    BORIC ACID (UNII: R57ZHV85D4)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    GUAR GUM (UNII: E89I1637KE)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-0431-044 in 1 CARTON10/30/201512/31/2017
    10.4 mL in 1 VIAL; Type 0: Not a Combination Product
    2NDC:0065-0431-3228 in 1 CARTON10/30/201512/31/2017
    20.4 mL in 1 VIAL; Type 0: Not a Combination Product
    3NDC:0065-0431-5740 in 1 CARTON10/30/201512/31/2017
    30.4 mL in 1 VIAL; Type 0: Not a Combination Product
    4NDC:0065-0431-3330 in 1 CARTON10/30/2015
    40.7 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34910/30/2015
    Labeler - Alcon Research Ltd (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kaysersberg Pharmaceuticals267486052manufacture(0065-0431)