SYSTANE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) GEL [ALCON LABORATORIES, INC.]

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SYSTANE (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL) GEL [ALCON LABORATORIES, INC.]
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NDC 0065-0454-07
Set ID 1d679d0f-cec2-a644-79cd-079607254bb9
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
    • for use as a protectant against further irritation or to relieve 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
    • replace cap after each use
  • STOP USE

    Stop use and ask a doctor if you experience any of the following:

    • you feel 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 1-800-757-9195
    alcon.medinfo@alcon.com
    www.systane.com

  • PRINCIPAL DISPLAY PANEL

    Systane®
    LUBRICANT EYE GEL

    GEL DROPS
    SOOTHING DRY EYE RELIEF

    Long-lasting formula
    Day or night protection

    #1 DOCTOR RECOMMENDED BRAND1
    LIQUID GEL

    STERILE
    10mL (1/3 FL OZ)

    Alcon

    Carton
  • INGREDIENTS AND APPEARANCE
    SYSTANE  
    polyethylene glycol 400 and propylene glycol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-0454
    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)  
    Guaraprolose (3500 Mpa.S At 1%) (UNII: 3A1I7376TC)  
    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
    1NDC:0065-0454-0710 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product02/11/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34902/09/2011
    Labeler - Alcon Laboratories, Inc. (008018525)
    Registrant - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Research LLC007672236manufacture(0065-0454)
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