SYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.]

SYSTANE (HYPROMELLOSE) GEL [ALCON LABORATORIES, INC.]
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NDC 0065-0474-01, 0065-0474-02
Set ID 5f74b161-ae41-d0e2-6ed9-8deca55d2c0f
Category HUMAN OTC DRUG LABEL
Packager Alcon Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART349
  • ACTIVE INGREDIENT

    Active ingredientPurpose
    Hypromellose (0.3%) Lubricant
  • Uses

    • for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
    • for use as a protectant against further irritation or to relieve dryness of the eye
  • Warnings

    For external use only

  • Do not use

    • if gel 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
    • 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.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    put 1 or 2 drops in the affected eye(s) as needed

  • Other information

    store between 15o – 30oC (59o – 86oF)

  • Inactive ingredients

    carbopol 980, phosphonic acid, purified water, sodium perborate and sorbitol.  May contain sodium hydroxide to adjust pH.

  • Questions?

    In the U.S. call toll-free
    1-866-393-6336
    alcon.medinfo@alcon.com

    TAMPER EVIDENT: For your protection, use only if pull tab is intact at time of purchase.


  • Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientPurpose
    Hypromellose (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 using
  • 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.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • put 1 or 2 drops in the affected eye(s) as needed
  • Other information

    • store at room temperature
  • Inactive ingredients

    carbopol 980, phosphonic acid, purified water, sodium perborate and sorbitol. May contain 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

    NDC  0065047401  

    Systane* 
    GEL
    LUBRICANT EYE GEL

    NIGHTTIME PROTECTION

    Delivers long-lasting relief of dry eye symptoms  

    Alcon®


    STERILE
    10g (0.34 FL OZ)

    Systane* Gel

    LUBRICANT EYE GEL

    Severe Dry Eye Relief

    TAMPER EVIDENT:
    For your protection, use only if pull tab is intact at time of purchase.

    U.S. Patent Nos. 5,607,698; 5,683,993; 5,858,996

    Processed in France with
    US-origin active ingredient

    Fort Worth, TX 76134 USA

    © 2011, 2014 Novartis

    * a trademark of Novartis

    25368500

    Carton

    Systane® 
    LUBRICANT EYE GEL

    NIGHT GEL

    COMFORTING
    DRY EYE RELIEF


    Long lasting gel
    for nighttime use


    Soothing relief

    #1 DOCTOR RECOMMENDED BRAND1
     
    GEL

    Alcon


    STERILE 10g
    (0.35 OZ)

    TAMPER EVIDENT: For your
    protection, use only if pull tab is
    intact at time of purchase.

    www.alconpatents.com

    1 Based on a survey of eye care
    professionals. Data on file.

    Processed in France with
    US-origin active ingredient for:
    Alcon Laboratories, Inc.
    Fort Worth, TX 76134 USA

    25368501-0519

    25368501

    LOT / EXP

    25368501-0519
  • INGREDIENTS AND APPEARANCE
    SYSTANE  
    hypromellose gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-0474
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hypromellose 2910 (4000 Mpa.s) (UNII: RN3152OP35) (Hypromellose 2910 (4000 Mpa.s) - UNII:RN3152OP35) Hypromellose 2910 (4000 Mpa.s)3 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)  
    Phosphonic Acid (UNII: 35V6A8JW8E)  
    Water (UNII: 059QF0KO0R)  
    Sodium Perborate (UNII: Y52BK1W96C)  
    Sorbitol (UNII: 506T60A25R)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-0474-011 in 1 CARTON12/15/2012
    110 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0065-0474-021 in 1 CARTON12/15/201212/31/2018
    23.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34912/15/2012
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Excelvision274234566manufacture(0065-0474) , label(0065-0474) , pack(0065-0474)
    Establishment
    NameAddressID/FEIBusiness Operations
    SERVIPACK571772875label(0065-0474) , pack(0065-0474)