Label: GENTEAL  MILD- hypromellose 2910 (4000 mpa.s) liquid 

  • NDC Code(s): 0078-0517-16, 0078-0517-24
  • Packager: Novartis Pharmaceutical Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 09/12

If you are a consumer or patient please visit this version.

  • OTC - ACTIVE INGREDIENT SECTION

    Hypromellose (0.2%)

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  • OTC - PURPOSE SECTION

    Lubricant

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  • INDICATIONS & USAGE SECTION

    • Relieves dryness of the eye.
    • Temporarily relieves discomfort due to minor irritations of the eye or from exposure to wind and sun.
    • As a protectant against further irritation.
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  • WARNINGS SECTION

    For external use only.

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  • OTC - DO NOT USE SECTION

    Do not use

    • if solution changes color or becomes cloudy
    • if you are sensitive to any ingredient in this product
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  • OTC - WHEN USING SECTION

    When using this product do not touch tip of container to any surface. Replace cap after using.

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  • OTC - STOP USE SECTION AND ASK A DOCTOR

    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
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  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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  • DOSAGE & ADMINISTRATION SECTION

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

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  • OTHER SAFETY INFORMATION

    Store between 15°-25°C (59°-77°F)

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  • INACTIVE INGREDIENT SECTION

    Boric acid, calcium chloride dihydrate, phosphonic acid, potassium chloride, purified water, sodium chloride and sodium perborate.  May contain hydrochloric acid and / or sodium hydroxide to adjust pH.

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  • OTC - QUESTIONS SECTION

    In the U.S., call toll-free 1-866-393-6336.
    MedInfo@AlconLabs.com
    Serious side effects associated with use of this product may be reported to this telephone number.
    www.genteal.com

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  • PRINCIPAL DISPLAY PANEL

    NDC 0078-0517-24

    Mild
    Dry Eye Relief

    GenTeal®
    LUBRICANT EYE DROPS

    LIQUID DROPS
    Fast, Soothing Relief

    Alcon®

    STERILE 15 mL (0.5 fl oz)

    Carton
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  • INGREDIENTS AND APPEARANCE
    GENTEAL   MILD
    hypromellose liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0078-0517
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Hypromellose 2910 (4000 Mpa.s) (Hypromellose 2910 (4000 Mpa.s)) Hypromellose 2910 (4000 Mpa.s) 0.002 L  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    Boric Acid  
    Calcium Chloride  
    Phosphonic Acid  
    Potassium Chloride  
    Water  
    Sodium Chloride  
    Sodium Perborate  
    Hydrochloric Acid  
    Sodium Hydroxide  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0078-0517-24 .015 L in 1 BOTTLE, DROPPER
    2 NDC:0078-0517-16 .025 L in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 09/14/2009
    Labeler - Novartis Pharmaceutical Corporation (002147023)
    Establishment
    Name Address ID/FEI Business Operations
    EXCELVISION AG 482198285 MANUFACTURE(0078-0517)
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