Label: GENTEAL TEARS SEVERE- hypromellose gel

  • NDC Code(s): 0065-8064-01
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 14, 2023

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active ingredientPurpose
    Hypromellose 0.3%. Lubricant
  • Uses

    • temporarily relieves discomfort due to minor irritations of the eye or to exposure to wind or sun
    • 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 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, phosphonic acid, purified 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

    Severe DRY EYE SYMPTOM RELIEF
    GEL

    GenTeal
    ® Tears
    LUBRICANT EYE GEL

    GEL
    Delivers Long-lasting relief of dry eye symptoms  

    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.
    Fort Worth, Texas 76134 USA

    Lot/Exp

    Alcon

    25368103

    Severe Dry Eye Symptom Relief

    Severe DRY EYE SYMPTOM RELIEF

    GenTeal® Tears

    LUBRICANT EYE GEL

    GEL

    Delivers long-lasting relief of dry eye symptoms

    STERILE 10g (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.

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


    ALCON

    16027802

    Severe Dry Eye Symptom Relief


  • INGREDIENTS AND APPEARANCE
    GENTEAL TEARS   SEVERE
    hypromellose gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-8064
    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).003 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Perborate (UNII: Y52BK1W96C)  
    Phosphonic Acid (UNII: 35V6A8JW8E)  
    Water (UNII: 059QF0KO0R)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Sorbitol (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-8064-011 in 1 CARTON12/31/2019
    110 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01812/31/2019
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Excelvision274234566manufacture(0065-8064) , label(0065-8064) , pack(0065-8064)