Label: MENTHOLATUM LIDOCAINE ICE- lidocaine hcl, menthol gel

  • NDC Code(s): 10742-1389-1
  • Packager: The Mentholatum Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 13, 2024

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  • Active ingredients

    Lidocaine HCl 4%

    Menthol 1%

  • Purpose

    Lidocaine HCl - Topical anesthetic

    Menthol – Topical analgesic

  • Uses

    temporarily relieves pain

  • Warnings

    For external use only

    Do not use

    • on large areas of the body or on cut, irritated or blistered skin
    • on puncture wounds
    • for more than one week without consulting a doctor

    When using this product

    • use only as directed
    • do not get into eyes
    • do not bandage tightly or apply external heat to the area of use

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness, rash, or irritation occurs
  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children.

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

  • Directions

    • adults and children 12 years and over: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
    • children under 12 years: ask a doctor
  • Inactive ingredients

    acrylates/C10-30 alkyl acrylate crosspolymer, alcohol, aloe barbadensis leaf juice, aminomethyl propanol, bis-vinyl dimethicone/dimecthicone copolymer, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, chlorphenesin, dicetyl phosphate, dimethicone, edetate disodium, ethoxydiglycol, glycerin, glyceryl monostearate, methoxypropanediol, phenoxyethanol, purified water, steareth-21

  • Package/Label Principal Display Panel

    Mentholatum Lidocaine Ice
  • INGREDIENTS AND APPEARANCE
    MENTHOLATUM LIDOCAINE ICE 
    lidocaine hcl, menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-1389
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS40 mg  in 1 mL
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETETH-20 PHOSPHATE (UNII: 921FTA1500)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERIN METHYL ETHER (UNII: 42ESM1DR47)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    WATER (UNII: 059QF0KO0R)  
    STEARETH-21 (UNII: 53J3F32P58)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-1389-11 in 1 CARTON08/01/2018
    180 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01708/01/2018
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Mentholatum Company002105757manufacture(10742-1389)
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