Label: GENTEAL TEARS GEL DROPS- polyethylene glycol 400 and propylene glycol gel

  • NDC Code(s): 0065-8067-01
  • 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
    Polyethylene Glycol 400 0.4%           Lubricant
    Propylene Glycol 0.3% Lubricant
  • Uses

    • for the temporary relief of burning and irritation due to dryness of the eye
    • for use as a protectant against further irritation or to relieve dryness of the eye
  • Warnings

    For external use only

  • Do not use

    • if this product 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:

    • 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

    • shake well before using
    • put 1 or 2 drops in the affected eye(s) as needed
  • Other information

    • store at room temperature
  • Inactive ingredients

    Aminomethylpropanol, boric acid, edetate disodium, hydroxypropyl guar, POLYQUAD® (polyquaternium-1) 0.001% preservative, potassium chloride, sodium chloride, sorbitol and purified water. May contain hydrochloric acid and /or sodium hydroxide to adjust pH.

  • Questions?

    In the U.S. call
    1-800-757-9195
    alcon.medinfo@alcon.com
    www.genteal.com

    Alcon Laboratories Inc.
    Fort Worth, TX 76134 USA  

    Made in the USA from domestic and imported materials 

    300038472-0920

    TOP OF THE CARTON

    GenTeal® Tears

    LUBRICANT EYE DROPS

    Severe Day + Night
    DRY EYE SYMPTOM RELIEF GEL DROPS

  • PRINCIPAL DISPLAY PANEL

    Severe Day + Night

    DRY EYE SYMPTOM RELIEF GEL DROPS  

    GenTeaL® Tears
    LUBRICANT EYE DROPS
    GEL DROPS
    Strength of a Gel,
    Convenience of a drop

    STERILE

    Alcon 8ml (0.3 FL OZ)

    TAMPER EVIDENT:

    For your protection, this bottle has a seal imprinted with Alcon around the neck. Do not use if seal is damaged or missing at time of purchase.

    GENTEAL® TEARS Gel Drops contains two lubricants to deliver the relief of a gel with the comfort and convenience of a drop.

    carton
  • INGREDIENTS AND APPEARANCE
    GENTEAL TEARS GEL DROPS 
    polyethylene glycol 400 and propylene glycol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-8067
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Polyethylene Glycol 400 (UNII: B697894SGQ) (Polyethylene Glycol 400 - UNII:B697894SGQ) Polyethylene Glycol 4004 mg  in 1 mL
    Propylene Glycol (UNII: 6DC9Q167V3) (Propylene Glycol - UNII:6DC9Q167V3) Propylene Glycol3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Aminomethylpropanol (UNII: LU49E6626Q)  
    Boric Acid (UNII: R57ZHV85D4)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Guaraprolose (3500 Mpa.S At 1%) (UNII: 3A1I7376TC)  
    Polidronium Chloride (UNII: 6716Z5YR3G)  
    Potassium Chloride (UNII: 660YQ98I10)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sorbitol (UNII: 506T60A25R)  
    Water (UNII: 059QF0KO0R)  
    Hydrochloric Acid (UNII: QTT17582CB)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-8067-018 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product02/04/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01802/04/2021
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Research LLC007672236manufacture(0065-8067)
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