Label: BURN- lidocaine hydrochloride gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 13, 2024

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  • Drug Facts

  • Active ingredient

    Lidocaine HCl 2.0%

  • Purpose

    Topical pain relief

  • Uses

    temporary pain relief associated with minor burns

  • Warnings

    For external use only

    Do not use

    • in large quantities, particularly over raw or blistered areas
    • near eyes, if this happens rinse thoroughly with water

    Stop use

    and ask a doctor if the condition worsens or persists for more than 7 days or clears up and returns.

    Keep out of reach of children.

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

  • Directions

    • apply an even layer of gel over cleaned affected area
    • not to be used on children under 12 years
  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Carbomer, Ethylhexylglycerin, Maltodextrin, Menthol, Polyethylene Glycol, Phenoxyethanol, Triethanolamine, Tocopheryl Acetate, Water.

  • Burn Gel

    Burn Gel Label

  • INGREDIENTS AND APPEARANCE
    BURN 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82942-1001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82942-1001-10.9 g in 1 PACKET; Type 0: Not a Combination Product10/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01710/01/2022
    Labeler - J&A Digital Inc. (040268672)
    Registrant - J&A Digital Inc. (040268672)
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