Label: MARATHON PAIN RELIEF TOPICAL ANALGESIC- menthol 3.0% lotion

  • 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 March 27, 2013

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  • ACTIVE INGREDIENT

    Menthol 3.0%

  • PURPOSE

    Topical analgesic

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a poison control center right away.

  • USES

    Temporarily relieves minor pain associated with

    • arthritis
    • simple backache
    • muscle strains
    • sprains
    • bruises
    • cramps
  • WARNINGS

    for external use only

    When using this product

    • use only as directed
    • do not bandage tightly or use with heating pad
    • avoid contact with eyes or mucus membranes
    • do not apply to wounds or damaged skin

    Stop using and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • redness is present
    • irritation deveops

    If pregnant or breast-feeding

    ask a health professional before use

  • DIRECTIONS

    adults and children over 12 years

    • apply generously to affected area
    • massage into painful area until throughly absorbed into skin
    • repeat as necessary, but no more than 4 times daily

    children 12 years or younger

    ask a doctor

  • INACTIVE INGREDIENTS

    Aloe Barbadensis Leaf, Anthemis Nobilis Extract, Arnica Montana Flower Extract, Blue 1, Butylene Glycol, Calendula Officinalis Extract, Capsicum rutescens Fruit, Carbomer, Centaurea Cyanus Extract, Cetearyl Alcohol, Coriandrum Sativum (Coriander) Fruit Oil, Emu Oil, Fragrance, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Hypericum Perforatum Extract, Matricaria Chamomilla Extract, Methylsulfonylmethane, Purified Water, Salix Alba (Willow) Baril Extract, SD Alcohol 40, Sorbitol, Tetrasodium EDTA, Tilia Sylvestris Extract, Triethanolamine.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    MARATHON PAIN RELIEF  TOPICAL ANALGESIC
    menthol 3.0% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) menthol3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CAPSICUM (UNII: 00UK7646FG)  
    CARBOMER 934 (UNII: Z135WT9208)  
    CENTAUREA CYANUS FLOWER (UNII: QZ239038YC)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CORIANDER OIL (UNII: 7626GC95E5)  
    EMU OIL (UNII: 344821WD61)  
    HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)  
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
    CHAMOMILE (UNII: FGL3685T2X)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    WATER (UNII: 059QF0KO0R)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    SORBITOL (UNII: 506T60A25R)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-001-13113 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/15/2013
    Labeler - Cosmetic Specialty labs, Inc. (032973000)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Specialty labs, Inc.032973000manufacture(58133-001)
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