Label: ARTHRIPAIN RELIEF- 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 April 13, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient                                                                            Purpose

    Menthol 1.25%.................................................................Pain relieving cream

  • PURPOSE

    Use  Temporarily relieves minor aches and  pains of muscles and joints associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    For external use only

    Do not use
    • on wounds or damaged skin

    When using this product

    • avoid contact with eyes or mucous membranes
    • do not bandage tightly

    Stop use and ask a doctor if

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

    Keep out of reach of children

  • Directions

    • Adult and children 2 years of age and older: Apply to affected area not more than  3 to 4 times daily.
    • Children under 2 years of age: Consult a physician.
  • INACTIVE INGREDIENT

    Inactive Ingredients: aloe vera gel, cetyl alcohol, cetyl esters
    (proprietary blend of esterfied fatty acids)(7.5%), cinnamon oil,
    eucalyptus oil, glyceryl stearate, grape seed oil, hypromellose, jojoba
    oil, peppermint oil, potassium sorbate, purified water, squalane, stearic
    acid, stearyl alcohol, tea tree oil, vegetable glycerin, wintergreen oil.

  • PRINCIPAL DISPLAY PANEL

    ArthriPain packaging

    package including display panel

  • INGREDIENTS AND APPEARANCE
    ARTHRIPAIN RELIEF 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50972-278
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol12.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Cetyl Esters Wax (UNII: D072FFP9GU)  
    Cinnamon Oil (UNII: E5GY4I6YCZ)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    HYPROMELLOSE (UNII: 3NXW29V3WO)  
    JOJOBA OIL (UNII: 724GKU717M)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SQUALANE (UNII: GW89575KF9)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50972-278-0157 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/01/2010
    Labeler - NDI Solutions LLC (828825989)
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