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GenTeal (Novartis Pharmaceuticals Corporation)

Available Formats

Dosage Form Package Information Links
GEL 1 TUBE in 1 CARTON (0078-0429-97) > 3.5 g in 1 TUBE Label Information
GEL 1 TUBE in 1 CARTON (0078-0429-47) > 10 g in 1 TUBE Label Information

Complete GenTeal Information

  • ACTIVE INGREDIENT

    Active ingredient Purpose
    Hypromellose 0.3%. Lubricant

  • Uses

    • relieves dryness of the eye.
    • temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun.
    • as a protectant against further irritation.

  • 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 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


    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 - 25ºC (59º - 77ºF)

  • Inactive ingredients

    carbopol 980, phosphoric acid, purifed water, sodium hydroxide, sodium perborate, and sorbitol


  • Questions?

    In the U.S., call toll-free 1-800-757-9195 (Mon-Fri 9AM-5PM CST).
    alcon.medinfo@alcon.com


  • PRINCIPAL DISPLAY PANEL

    NDC 0078-0429-47
    GEL

    Severe
    DRY EYE SYMPTOM RELIEF

    GenTeal Tears

    GEL

    Delivers Long-lasting relief of dry eye symptoms

    New Design

    STERILE

    10 g (0.34 FL OZ)

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

    Distributed by:
    ALCON LABORATORIES, INC.
    6201 South Freeway
    Fort Worth, Texas 76134 USA
    a Novartis Company
    Country of Origin: Switzerland
    © 2016 Novartis

    US 25355200

    LOT/EXP

    Carton

    NDC 0078-0429-47

    Severe DRY EYE SYMPTOM RELIEF

    GenTeal® Tears
    LUBRICANT EYE GEL

    GEL

    Delivers long-lasting relief of dry eye symptoms

    STERILE 10 g (0.34 FL OZ)

    Active ingredient: Hypromellose (0.3%)
    Uses: See carton for Uses.
    Warnings: See carton for Warnings. When using this product do not touch tip of container to any surface. Replace cap after using.
    Directions: Put 1 or 2 drops in the affected eye(s) as needed.
    Other information: Store between 15°- 25°C (59°- 77°F).

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

    US15025500

    Distributed by:
    ALCON LABORATORIES, INC., a Novartis company
    6201 South Freeway, Fort Worth, Texas 76134 USA

    © 2016 Novartis

    Alcon®

    EXP
    LOT




    Label



  • INGREDIENTS AND APPEARANCE
    GENTEAL  SEVERE
    hypromellose gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0078-0429
    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) .003 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM PERBORATE (UNII: Y52BK1W96C)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0078-0429-97 1 in 1 CARTON 09/14/2009 02/28/2015
    1 3.5 g in 1 TUBE; Type 0: Not a Combination Product
    2 NDC:0078-0429-47 1 in 1 CARTON 09/14/2009
    2 10 g in 1 TUBE; Type 0: Not a Combination Product
    3 NDC:0078-0429-57 2 in 1 CARTON 09/14/2009
    3 10 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 09/14/2009
    Labeler - Novartis Pharmaceuticals Corporation (002147023)
    Establishment
    Name Address ID/FEI Business Operations
    Akorn AG 482198285 manufacture(0078-0429)
    Establishment
    Name Address ID/FEI Business Operations
    Excelvision 274234566 manufacture(0078-0429)