Label: GENTEAL TEARS NIGHT-TIME- mineral oil, white petrolatum ointment

  • NDC Code(s): 0065-0518-01
  • Packager: Alcon Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 5, 2024

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  • ACTIVE INGREDIENT

  • PURPOSE

    Active ingredientsPurpose
    Mineral oil 3 %Lubricant
    White petrolatum 94 %Lubricant
  • Uses

    • for use as a lubricant to prevent further irritation
    • to relieve dryness of the eye.
  • Warnings

    For external use only

  • Do not use

    • if you are sensitive to any ingredient in this product
  • When using this product

    • do not touch tip of container to any surface
    • replace cap after using
  • 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

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.

  • Other information

    store at 8° – 27° C (46° – 80° F).

  • Inactive ingredient:

    Anhydrous liquid lanolin

  • Questions?

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

  • PRINCIPAL DISPLAY PANEL

    Severe
    DRY EYE SYMPTOM RELIEF 

    OINTMENT

    GenTeal®
    Tears

    LUBRICANT EYE OINTMENT

    GenTeal® Night-time PM ointment provides long-lasting relief for night-time comfort.

    NIGHT-TIME OINTMENT
    Long-lasting Night-time Relief

    STERILE 3.5 g (0.12 FL OZ)

    Alcon®

    TAMPER EVIDENT:
    For your protection, do not use if carton security seal is damaged or missing at the time of purchase.

    Distributed by:
    ALCON LABORATORIES, INC.,
    6201 South Freeway
    Fort Worth, Texas 76134 USA
    Country of Origin: Belgium

    1635962-0723

    LOT:
    EXP.:

    Please read this carton carefully and keep for future reference.

    Carton Front
    Carton Back

    Severe
    DRY EYE SYMPTOM RELIEF 

    OINTMENT

    GenTeal®
    Tears

    LUBRICANT EYE OINTMENT

    GenTeal® Night-time PM ointment provides long-lasting relief for night-time comfort.

    NIGHT-TIME OINTMENT
    Long-lasting Night-time Relief

    STERILE 3.5 g (0.12 FL OZ)

    Alcon

    TAMPER EVIDENT:
    For your protection, do not use if carton security seal is damaged or missing at the time of purchase.

    Distributed by:
    ALCON LABORATORIES, INC.,
    6201 South Freeway
    Fort Worth, Texas 76134 USA
    Country of Origin: Spain

    3601067 01-0724

    Carton2 Front
    Carton2 Back
  • INGREDIENTS AND APPEARANCE
    GENTEAL   TEARS NIGHT-TIME
    mineral oil, white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0065-0518
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Mineral Oil (UNII: T5L8T28FGP) (Mineral Oil - UNII:T5L8T28FGP) Mineral Oil0.03 g  in 1 g
    Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum0.94 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Lanolin (UNII: 7EV65EAW6H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0065-0518-011 in 1 CARTON09/05/2019
    13.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01809/05/2019
    Labeler - Alcon Laboratories, Inc. (008018525)
    Establishment
    NameAddressID/FEIBusiness Operations
    Novartis Manufacturing370205429manufacture(0065-0518)
    Establishment
    NameAddressID/FEIBusiness Operations
    Siegfried El Masnou, S.A.462029349manufacture(0065-0518)
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