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GenTeal (Novartis Pharmaceutical Corporation)

Available Formats

Dosage Form Package Information Links
LIQUID .015 L in 1 BOTTLE, DROPPER (0078-0517-24) Label Information
LIQUID .025 L in 1 BOTTLE, DROPPER (0078-0517-16) Label Information

Complete GenTeal Information

  • OTC - ACTIVE INGREDIENT SECTION

    Hypromellose (0.2%)


  • OTC - PURPOSE SECTION

    Lubricant


  • 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.

  • WARNINGS SECTION

    For external use only.


  • 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

  • OTC - WHEN USING SECTION

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


  • 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

  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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


  • DOSAGE & ADMINISTRATION SECTION

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


  • OTHER SAFETY INFORMATION

    Store between 15°-25°C (59°-77°F)


  • 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.


  • 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


  • 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

  • INGREDIENTS AND APPEARANCE
    GENTEAL   MILD
    hypromellose liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0078-0517
    Route of Administration OPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Hypromellose 2910 (4000 Mpa.s) (UNII: RN3152OP35) (Hypromellose 2910 (4000 Mpa.s) - UNII:RN3152OP35) Hypromellose 2910 (4000 Mpa.s) 0.002 L  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    Boric Acid (UNII: R57ZHV85D4)  
    Calcium Chloride (UNII: M4I0D6VV5M)  
    Phosphonic Acid (UNII: 35V6A8JW8E)  
    Potassium Chloride (UNII: 660YQ98I10)  
    Water (UNII: 059QF0KO0R)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Perborate (UNII: Y52BK1W96C)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    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)