Label: RELIEF PAIN RELIEVING CREAM- 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 November 10, 2014

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  • ACTIVE INGREDIENT

    Menthol 2.5%

  • PURPOSE

    Counterirritant

  • USAGE

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

  • WARNINGS

    For external use only. If condition worsens, or if symptons persist for more than 7 days or clear up and occur again in a few days, discontinue use of this product and consult a physician.

    Do Not Use

    • on wounds or damaged skin
    • when bandaged tightly
    • with other topical products
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

  • DIRECTIONS

    • Adults and children 2 years old and older: apply a small amount to affected area not more than 3 to 4 times daily.
    • Gently massage until absorbed.
    • Children under 2 years of age: consult a doctor.
  • INACTIVE INGREDIENTS

    Aloe Barbadensis Leaf Juice, Caprylic/Capric Triglycerides, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Citrus Aurantium Dulcis (Sweet Orange) Oil, Cymbopogon Martini (Palmarosa) Oil, Deionized Water, Diazolidinyl Urea, Eucalyptus Globulus Leaf Oil, Glycerine, Iodopropynyl Butylcarbamate, L-Arginine, Lavandula Angustifolia (Lavender) Oil, Lecithin, Mentha Piperita (Peppermint Oil), Tocopherol, Methylsulfonylmethane, Tocopheryl Acetate, Triethanolamine

  • PRINCIPAL DISPLAY PANEL

    CONTAINER LABEL

  • INGREDIENTS AND APPEARANCE
    RELIEF PAIN RELIEVING CREAM 
    menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58559-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    PALMAROSA OIL (UNII: 0J3G3O53ST)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    WATER (UNII: 059QF0KO0R)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ARGININE (UNII: 94ZLA3W45F)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58559-001-015 g in 1 BLISTER PACK05/22/2004
    2NDC:58559-001-0282 g in 1 BOTTLE, WITH APPLICATOR05/22/2004
    3NDC:58559-001-03115 g in 1 TUBE05/22/2004
    4NDC:58559-001-04450 g in 1 BOTTLE, PUMP05/22/2004
    5NDC:58559-001-053600 g in 1 BOTTLE, PUMP05/22/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/22/2004
    Labeler - Corganics, LP (028162522)
    Establishment
    NameAddressID/FEIBusiness Operations
    Naturich Cosmetique Labs124281663manufacture(58559-001)
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