Label: MENTHOZEN- methyl salicylate, menthol, capsaicin cream

  • 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 October 21, 2021

If you are a consumer or patient please visit this version.

  • DRUG FACTS:

  • ACTIVE INGREDIENTS:

    Methyl Salicylate 20.00%

    Menthol 5.00%

    Capsaicin 0.0375%

    Topical Analgesic

  • USES:

    For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

  • WARNINGS:

    • For external use only.
    • Avoid contact with the eyes.
    • If condition worsens, or if symptoms persist for more than seven days or clear up and occur again with a few days, discontinue use of this product and consult a physician.

    Keep out of reach of children.

    If swallowed, consult physician.

    Do not apply

    • to wounds or damaged skin.
    • Do not bandage tightly.

    If pregnant or breast feeding,

    contact a physician prior to use.

  • 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.

  • OTHER INFORMATION:

    Store at room temperature.

  • INACTIVE INGREDIENTS:

    Aloe Barbadensis Leaf Extract, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetyl Alcohol, DMDM Hydantoin, Emulsifying Wax, Ethoxydiglycol, Ethylhexylglycerin, Glyceryl Stearate, Ilex Paraguayensis (Yerba Mate’) Extract, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polysorbate-20, Stearic Acid, Stearyl Alcohol, Triethanolamine, Xanthan Gum, Zemea (Corn) Propanediol.

  • Pckage Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    MENTHOZEN 
    methyl salicylate, menthol, capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71574-600
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE200 mg  in 1 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 mL
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.375 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71574-600-721 in 1 BOX10/01/2018
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/01/2018
    Labeler - Village Pharma LLC (080749749)