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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 October 23, 2012

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  • Active Ingredient

    Lidocaine HCl 0.50%
  • Purpose

    Topical Anesthetic

  • Uses

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

  • 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.
  • 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.

  • Principal Display Panel

    UNIQUELY NY DRTM SINCE 1960

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


  • INGREDIENTS AND APPEARANCE
    DUANE READE BURN RELIEF  PAIN RELIEVING GEL
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67732-406
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    MENTHOL (UNII: L7T10EIP3A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67732-406-16226 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/13/2012
    Labeler - DUANE READE INC. (011988995)
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