Label: DUANE READE BURN RELIEF PAIN RELIEVING GEL- lidocaine hydrochloride gel 

  • Label RSS
  • 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 10/12

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  • Active Ingredient

    Lidocaine HCl 0.50%
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  • Purpose

    Topical Anesthetic

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  • Uses

    • temporary pain relief
    • 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 symptoms persists for more than 7 days.
    • Symptoms clear up and occur again within a few days.

    Keep out of 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

    Aloe Barbadensis Leaf Juice, Water, Propylene Glycol, Glycerin, Isopropyl Alcohol, Triethanolamine, Polysorbate 80, Carbomer, Diazolidinyl urea, Disodium EDTA, Menthol, Yellow 5, Blue 1.

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  • Principal Display Panel

    UNIQUELY NY DRTM SINCE 1960

    burn
    relief
    pain relieving gel
    with Lidocaine
    NET WT 8 OZ (227 g)
    ZDR008A0.jpg


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  • INGREDIENTS AND APPEARANCE
    DUANE READE BURN RELIEF  PAIN RELIEVING GEL
    lidocaine hydrochloride gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:67732-406
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE 0.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    TROLAMINE  
    ISOPROPYL ALCOHOL  
    EDETATE DISODIUM  
    ALOE VERA LEAF  
    PROPYLENE GLYCOL  
    GLYCERIN  
    POLYSORBATE 80  
    DIAZOLIDINYL UREA  
    MENTHOL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67732-406-16 226 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 11/13/2012
    Labeler - DUANE READE INC. (011988995)
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