Label: BURN- lidocaine hydrochloride gel

  • NDC Code(s): 72459-101-01
  • Packager: Yiwu Ori-Power Medtech Co., Ltd.
  • 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 August 27, 2023

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  • Drug Facts

  • Active ingredient

    Lidocaine Hydrochloride 2%

  • 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 burn gel over deaned affected area not more than 3-4 times daily
    • not to be used on children under 12 years of age.
  • Inactive ingredients

    Aloe BarbadensisLeaf Juice, Carbomer, Ethylhexgilglycerin, Maltodextrin, Menthol, Polyethylene Glycol, Phenoxyethanol, Triethanolamine, Tocopheryl Acetate, Water.

  • PRINCIPAL DISPLAY PANEL

    image of pouch label

  • INGREDIENTS AND APPEARANCE
    BURN 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72459-101
    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:72459-101-010.9 g in 1 POUCH; Type 0: Not a Combination Product08/28/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/28/2023
    Labeler - Yiwu Ori-Power Medtech Co., Ltd. (560451976)
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