Label: AVADERM- lidocaine hcl, menthol cream

  • Category: HUMAN OTC DRUG LABEL

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 July 2, 2015

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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:69677-020
    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:69677-020-01120 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/08/2015
    Labeler - MAS Management Group Inc. (079363782)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, Inc.969241041manufacture(69677-020)
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