Label: GENTEAL  NIGHT-TIME PM- mineral oil and petrolatum ointment 

  • NDC Code(s): 0078-0473-97
  • Packager: Novartis Pharmaceutical Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/12

If you are a consumer or patient please visit this version.

  • OTC - ACTIVE INGREDIENT SECTION

    Mineral oil (15%)
    White petrolatum (85%)

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  • OTC - PURPOSE SECTION

    Lubricant

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  • INDICATIONS & USAGE SECTION

    • Relieves dryness of the eye.
    • Temporarily relieves discomfort due to minor irritations of the eye or from exposure to wind or sun.
    • As a protectant against further irritation.
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  • WARNINGS SECTION

    For external use only.

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  • OTC - DO NOT USE SECTION

    • if you are sensitive to any ingredient in this product
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  • OTC - WHEN USING SECTION

    When using this product do not touch tip of container to any surface. Replace cap after using.

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  • OTC - STOP USE SECTION

    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
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  • OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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  • DOSAGE & ADMINISTRATION SECTION

    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.

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  • OTHER SAFETY INFORMATION

    Store between 15°- 25°C (59°-77°F).

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  • INACTIVE INGREDIENT SECTION

    None listed.

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  • OTC - QUESTIONS SECTION

    In the U.S. call toll-free 1-866-393-6336; MedInfo@AlconLabs.com
    Serious side effects associated with use of this product may be reported to this telephone number.
    www.genteal.com

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  • PRINCIPAL DISPLAY PANEL

    NDC 0078-0473-97

    Night-time PM
    Dry Eye Relief

    GenTeal®
    LUBRICANT EYE OINTMENT

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

    NIGHT-TIME OINTMENT
    Long-lasting Night-time Relief

    Alcon®

    STERILE 3.5 g (0.12 fl oz)

    Carton
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  • INGREDIENTS AND APPEARANCE
    GENTEAL   NIGHT-TIME PM
    white petrolatum ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0078-0473
    Route of Administration OPHTHALMIC DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Mineral Oil (Mineral Oil) Mineral Oil 0.15 g  in 1 g
    Petrolatum (Petrolatum) Petrolatum 0.85 g  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0078-0473-97 1 in 1 CARTON
    1 3.5 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part349 12/14/2009
    Labeler - Novartis Pharmaceutical Corporation (002147023)
    Establishment
    Name Address ID/FEI Business Operations
    Bausch & Lomb Incorporated 807927397 MANUFACTURE(0078-0473)
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