Label: GENTEAL TEARS MODERATE PRESERVATIVE FREE- dextran 70, hypromellose 2910 solution/ drops

  • NDC Code(s): 0065-8063-01
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 14, 2023

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  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Dextran 70 0.1%Lubricant
    Hypromellose 2910 0.3%Lubricant
  • PURPOSE

  • Uses

    • temporary relief of discomfort due to minor irritations of the eye, or to exposure to wind or sun
  • Warnings

    For external use only

  • Do not use

    • if this solution changes color or becomes cloudy
    • if you are sensitive to any ingredient in this product
  • When using this product

    • to avoid contamination, do not touch tip of container to any surface
    • do not reuse
    • once opened, discard
  • 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.

    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 are room temperature 15o – 25o C (59o – 77o F)
  • Inactive ingredients

    potassium chloride, purified water, sodium borate, sodium chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

  • Questions?               

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

  • PRINCIPAL DISPLAY PANEL

    PRESERVATIVE FREE

    Moderate DRY EYE SYMPTOM RELIEF

    GenTeal    ® Tears

    LUBRICANT EYE DROPS

    LIQUID DROPS
    Fast, Soothing Relief
    Preservative Free Formula

    Previously TEARS NATURALE® FREE LUBRICANT EYE DROPS

    STERILE  36 Single-Use Vials 0.9 mL (0.03 FL OZ) Each

    Alcon

    GenTeal® Tears Lubricant Eye Drops
    Preservative Free provide lasting relief
    for moderate dry eye with the
    convenience of a vial.

    TAMPER EVIDENTY:
    Do not use if vial is damaged or opened.

    Distributed by:
    Alcon Laboratories, Inc.,
    6201 South Freeway
    Fort Worth, Texas 76134

    Country of Origin: France

    435581

    Carton Label
    Carton Label
  • INGREDIENTS AND APPEARANCE
    GENTEAL TEARS MODERATE PRESERVATIVE FREE 
    dextran 70, hypromellose 2910 solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-8063
    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)3 mg  in 1 mL
    Dextran 70 (UNII: 7SA290YK68) (Dextran 70 - UNII:7SA290YK68) Dextran 701 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Potassium Chloride (UNII: 660YQ98I10)  
    Water (UNII: 059QF0KO0R)  
    Sodium Borate (UNII: 91MBZ8H3QO)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-8063-0136 in 1 CARTON07/03/2018
    1.9 mL in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01807/03/2018
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kaysersberg Pharmaceuticals267486052manufacture(0065-8063)
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