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
  • Marketing Status: OTC monograph final

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 June 30, 2022

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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
    a Novartis company

    Country of Origin: France

    © 2015 Novartis
    *trademark of Novartis

    435580

    W9012667-1115

    carton 2
  • 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 CARTON12/22/2017
    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 finalpart34912/22/2017
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kaysersberg Pharmaceuticals267486052manufacture(0065-8063)
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