Label: BURN- lidocaine hydrochloride gel

  • NDC Code(s): 43473-048-01
  • Packager: Nantong Health & Beyond Hygienic Products Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 15, 2024

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  • Drug Facts

  • Active Ingredient

    Lidocaine HCl 2.0%

  • Purpose

    Topical Pain Relief

  • Uses

    Temporary pain relief for minor burns.

  • Warnings:

    For external use only

    Do not use

    • ln large quantities, particularly over raw or blistered areas.
    • Near the eyes; if this happens rinse thoroughly with water.

    Stop use and ask doctor if

    • Condition worsens or persists for more than 7 days or clears up and occurs 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

    • For adults and children 2 years and older: apply to affected area not more than 4 times daily.
    • Children under 2 years old: do not use, consult a doctor.
  • lnactive lngredients

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

  • Questions or Comments?

    1-833-420-1183

  • Burn Gel

    image of pouch label

  • INGREDIENTS AND APPEARANCE
    BURN 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43473-048
    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:43473-048-010.9 g in 1 POUCH; Type 0: Not a Combination Product11/04/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/04/2022
    Labeler - Nantong Health & Beyond Hygienic Products Inc. (421280161)
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