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
  • 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 21, 2022

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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 Product02/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34902/01/2021
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Alcon Research LLC007672236manufacture(0065-8067)
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