Label: GENTEAL TEARS (MODERATE)- dextran 70, glycerin, hypromellose solution/ drops

  • NDC Code(s): 0065-0426-36, 0065-0426-37
  • 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 29, 2022

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  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Dextran 70 0.1%Lubricant
    Glycerin 0.2%Lubricant
    Hypromellose 0.3%Lubricant
  • Uses

    • temporary relief of burning and irritation due to dryness of the eye
    • as a protectant against further irritation
    • 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

    • do not touch tip of container to any surface to avoid contamination
    • replace cap after each use
  • STOP USE

    Stop use and ask a doctor if you experience any of the following:

    • you feel 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 at room temperature
  • Inactive ingredients:

    boric acid, calcium chloride, glycine, hydrochloric acid and/or sodium hydroxide (to adjust pH), magnesium chloride, POLYQUAD* (polyquaternium-1) 0.001% preservative, polysorbate 80, potassium chloride, purified water, sodium chloride, zinc chloride.

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    NDC  0065-0426-36

    Moderate DRY EYE SYMPTOM RELIEF

    GenTeal* Tears
    LUBRICANT EYE DROPS

    LIQUID DROPS
    Fast Soothing Relief

    PREVIOUSLY TEARS NATURALE* FORTE

    STERILE 15 mL (0.5 FL OZ)

    Alcon

    TAMPER EVIDENT:
    For your protection, this bottle has an
    imprinted seal around the neck. Do
    not use if seal is damaged or missing
    at time of purchase.

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

    Country of Origin: USA

    300048636-0621

    Carton Label

    NDC  0065-0426-36

    Moderate DRY EYE SYMPTOM RELIEF

    GenTeal* Tears
    LUBRICANT EYE DROPS

    LIQUID DROPS
    Fast Soothing Relief

    PREVIOUSLY TEARS NATURALE* FORTE

    STERILE 15 mL (0.5 FL OZ)

    Alcon® 

    TAMPER EVIDENT:
    For your protection, this bottle has an imprinted seal around the neck. Do not use if seal is damaged or missing at time of purchase.

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

    Country of Origin: USA
    © 2015 Novartis
    *trademark of Novartis

    0065-0426
  • INGREDIENTS AND APPEARANCE
    GENTEAL TEARS (MODERATE)  
    dextran 70, glycerin, hypromellose solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-0426
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dextran 70 (UNII: 7SA290YK68) (Dextran 70 - UNII:7SA290YK68) Dextran 701 mg  in 1 mL
    Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin2 mg  in 1 mL
    Hypromelloses (UNII: 3NXW29V3WO) (Hypromelloses - UNII:3NXW29V3WO) Hypromelloses3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Boric Acid (UNII: R57ZHV85D4)  
    Calcium Chloride (UNII: M4I0D6VV5M)  
    Glycine (UNII: TE7660XO1C)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Magnesium Chloride (UNII: 02F3473H9O)  
    Polidronium Chloride (UNII: 6716Z5YR3G)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Potassium Chloride (UNII: 660YQ98I10)  
    Water (UNII: 059QF0KO0R)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Zinc Chloride (UNII: 86Q357L16B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-0426-361 in 1 CARTON03/01/2016
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:0065-0426-372 in 1 CARTON03/01/2016
    215 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34903/01/2016
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Research LLC007672236manufacture(0065-0426)
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