Label: AVADERM- lidocaine hcl, menthol cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 22, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient:

    Lidocaine HCL             4.00%                        Topical Analgesic

    Menthol                      1.00%                        Topical Analgesic

  • PURPOSE

    Indications: For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or skin irritations.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, consult physician.

  • INDICATIONS & USAGE

    AvaDerm

    (Lidocaine - Menthol)

  • DOSAGE & ADMINISTRATION

    Directions:

    • Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
    • Children under two-years of age: consult a physician.
  • WARNINGS

    Warnings:

    • Avoid contact with eyes. 
    • If symptoms persist for more than seven days, discontinue use and consult physician.
    • Do not use in large quantities, particularly over raw surfaces or blistered areas.
    • Do not bandage tightly.
    • If pregnant or breast feeding, contact physician prior to use.
  • INACTIVE INGREDIENT

    Other Ingredients:

    aqua (deionized water), arnica montana flower extract, C13-14 isoparaffin, cetearyl alcohol, chondroitin sulfate, emu oil, ethylhexylglycerin, glucosamine sulfate, glycerin, glyceryl stearate, laureth-7, methylsulfonylmethane (MSM), PEG-100 stearate, phenoxyethanol, polyacrylamide, propylene glycol, stearic acid, triethanolamine, urea.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    AVADERM 
    lidocaine hcl, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65121-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
    EMU OIL (UNII: 344821WD61)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    LAURETH-7 (UNII: Z95S6G8201)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    UREA (UNII: 8W8T17847W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65121-300-01120 g in 1 PACKAGE; Type 0: Not a Combination Product06/10/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/10/2015
    Labeler - Pure Source, LLC (080354456)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456manufacture(65121-300)
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