Label: DUANE READE ALOE VERA PAIN RELIEVING- lidocaine and menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 11/12

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

  • Active Ingredients

    Lidocaine 0.50%
    Menthol  0.10%
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  • Purpose

    Topical Analgesic

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  • Uses

    • temporary relief of pain and itching
    • helps relieve and soothes pain from sunburn, minor burns, cuts, scrapes, skin irritations and insect bites.
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  • Warnings

    For external use only

    Do not use

    • in large quantities, particularly over raw surfaces or blistered areas.

    When using this product

    • avoid contact with eyes.

    stop use and ask a doctor if

    • conditions worsens or if symptoms persists for more than 7 days.
    • symptoms clear up and occur again within a few days.

    Keep out of the reach of children.

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

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  • Directions

    • adults and children 2 years of age and older.apply to affected area not more than 3 to 4 times daily
    • children under 2 years of age: do not use, ask a doctor.
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  • Inactive Ingredients

    Water, Aloe Barbadensis Leaf Juice, SD Alcohol 40-B, Propylene Glycol, Glycerin, Polysorbate 20, Carbomer, Triethanolamine, Diazolidinyl urea, Disodium EDTA, Tocopherol, Blue 1.

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  • Principal Display Panel

    UNIQUELY NY DRTM SINCE 1960

    aloe
    vera

    pain relieving gel
    with Lidocaine and Menthol

    NET WT 16 OZ (454 g)
    ZDR011A0.jpg


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  • INGREDIENTS AND APPEARANCE
    DUANE READE ALOE VERA  PAIN RELIEVING
    lidocaine gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:67732-408
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE (LIDOCAINE) LIDOCAINE 0.5 g  in 100 g
    MENTHOL (MENTHOL) MENTHOL 0.10 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    TROLAMINE  
    TOCOPHEROL  
    EDETATE DISODIUM  
    ALOE VERA LEAF  
    PROPYLENE GLYCOL  
    GLYCERIN  
    POLYSORBATE 20  
    DIAZOLIDINYL UREA  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67732-408-19 454 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 10/23/2012
    Labeler - DUANE READE INC. (011988995)
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