Label: LIDOCAINE HYDROCHLORIDE liquid

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

Drug Label Information

Updated November 12, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Lidocaine HCl 2.0%

  • Purpose

    Topical pain relief

  • Use

    Temporarily relieves pain associated with minor burns.

  • Warnings

    For external use only.

    Do not use

    • in eyes, if contact occurs rinse thoroughly with water
    • in large quantities, particularly over raw or blistered areas

    Stop use and ask a doctor if 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 Poison Control Center right away
  • Directions

    • adults and children 2 years of age and older: spray an even layer of burn spray over affected area not more than 3-4 times daily
    • children under 2 years of age: consult a doctor
  • Inactive ingredients

    aloe vera, diazolidinyl urea, propylene glycol, purified water
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  • QUESTIONS

    Questions? 1.800.835.2263

  • PRINCIPAL DISPLAY PANEL

    Bottle Bottle LabelLabel

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE HYDROCHLORIDE 
    lidocaine hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0934(NDC:61010-5100)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-0934-0159.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/16/2023
    2NDC:0924-0934-02118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/16/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/16/2023
    Labeler - Acme United Corporation (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-0934) , repack(0924-0934)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-0934) , repack(0924-0934)
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