Label: JOINT AND MUSCLE PAIN RELIEF- menthol cream

  • NDC Code(s): 62742-4219-1, 62742-4219-2
  • Packager: Allure Labs
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 September 8, 2022

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  • ACTIVE INGREDIENT

    Active ingredient

    Menthol 1.5%

  • PURPOSE

    Purpose

    Topical analgesic

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with

    simple backache

    arthritis

    strains

    bruises

    sprains

  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    on wounds or damaged skin

  • WHEN USING

    When using this product

    avoid contact with eyes

    do not bandage tightly

  • STOP USE

    Stop use and ask a doctor if

    condition worsens

    irritation occurs

    symptoms persist for more than 7 days or clear up and occur again within a few days

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 2 years of age and olden Apply to affected area not more than 3 to 4 times daily Children under 2 years of age: ask a doctor

  • OTHER SAFETY INFORMATION

    Other Information

    Store in a cool, dry place away from light

    If pregnant or breast-feeding, ask a health professional before use

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Glycerin,Cannabis Sativa Seed Oil, Arnica Montana Flower Extract, Glyceryl Stearates, Cetearyl Alcohol,Ceteareth-20,

    PEG-100 Stearate,Butyrospermum Parkii (Shea) Butter, Cetyl Esters,Ammonium Acryloyldimethyltaurate/VP Copolymer,

    Aloe Barbadensis Leaf Juice, Ethoxydiglycol, Dimethicone, Dipotassium Glycyrrhizate,Dimethyl Sulfone, Sodium Phytate,

    Pyridoxine HCI, Methyl Gluceth-20, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Boswellia Carterii Oil,Menthe Piperita (Peppermint) Oil,Glucosamine HCI, Citric Acid, Phenoxyethanol,Potassium Sorbate,Sodium Benzoate, Ethylhexylglycerin,Tocopherol,

    Monoglycerides,Sunflower Oil,Beta-Sitosterol, Squalene,Limonene, Linalool.

  • PRINCIPAL DISPLAY PANEL

    Joint & Muscle pain relief

  • INGREDIENTS AND APPEARANCE
    JOINT AND MUSCLE PAIN RELIEF 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4219
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    DIACETYLATED MONOGLYCERIDES (UNII: 5Z17386USF)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    WATER (UNII: 059QF0KO0R)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    SQUALENE (UNII: 7QWM220FJH)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4219-21 in 1 CARTON09/08/2022
    1NDC:62742-4219-157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01509/08/2022
    Labeler - Allure Labs (926831603)
    Registrant - Allure Labs (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs926831603manufacture(62742-4219)
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