Label: MENTHOL 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 December 11, 2020

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  • ACTIVE INGREDIENT

    Menthol  10%

  • PURPOSE

    Topical Analgesic

  • USES

    Aid for temporary local relief of minor pain in muscles or joints.

  • WARNINGS

    • For external use only.
    • Avoid contact with eyes.
    • If symptoms persist for more than seven days, discontinue use and consult a physician.

    IF PREGNANT OR BREAST – FEEDING:

    • Ask a health professional before use.
  • KEEP OUT OF REACH OF CHILDEN:

    • If swallowed, get medical help or contact a Poison Control Center right away.
    • Emergency Number: 1-800-222-1222
  • 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.
  • Additional Information

    Store at room temperature.

  • Inactive ingredients

    Aqua, Caprylic/Capric Triglyceride, Alcohol Denat., Stearic Acid, Cetyl Alcohol, Dimethicone, Glyceryl Stearate, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol, Helianthus Annuus Seed Oil, Butyrospermum Parkii Butter, Cannabis Sativa Seed Oil, Glycereth-26, Persea Gratissima Oil, Stearyl Alcohol, Sodium Polyacrylate, Aloe Barbadensis Leaf Extract, Glycerin, Boswellia Serrata Extract, Melaleuca Alternifolia Leaf Oil, Mentha Arvensis Herb Oil, Arnica Montana Flower Extract.

  • PRINCIPAL DISPLAY PANEL

    PAIN RUB

  • INGREDIENTS AND APPEARANCE
    MENTHOL 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73143-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERETH-26 (UNII: NNE56F2N14)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    MENTHA ARVENSIS FLOWER OIL (UNII: Q129Z1W6Y2)  
    ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    MELALEUCA ALTERNIFOLIA FLOWERING TOP (UNII: 5AZ4S6N66F)  
    WATER (UNII: 059QF0KO0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE 1000 (UNII: MCU2324216)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73143-010-0396 g in 1 CAN; Type 0: Not a Combination Product07/18/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/18/2019
    Labeler - Jag Alliance, LLC (081456767)
    Registrant - Chemco Corporation (032495954)
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