Label: GENTEAL TEARS SEVERE- hypromellose gel

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

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 October 26, 2021

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
    A Novartis Division 

    Lot/Exp

    Alcon

    25368102 

    Carton


  • 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 CARTON12/14/2019
    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 finalpart34912/14/2019
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Excelvision274234566manufacture(0065-8064) , label(0065-8064) , pack(0065-8064)