Label: COLD SPOT POINT RELIEF- menthol gel

  • 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 October 13, 2011

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  • ACTIVE INGREDIENT

    menthol - usp 12%

    methyl salicylate 4%

  • INACTIVE INGREDIENT

    aqua (deionized water), arnica montana flower (arnica) extract, boswella serrata extract, brtomelain, carbomer, diazolidinyl urea, eucalyptus globulus oil, glycrrhiza glabra (licorice) extract, ilex paraguariensis leaf (yerba mate) extract, menth piperita (pepperment) oil, methyl paraben, MSM (dimethyl sulfone) polysorbate-80, SD-alcohol 40B, triethanolamine

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, consult physician.

  • WARNINGS

    for external use only

    avoid contact with eyes

    do not apply to open wounds or damaged skin

    if symptoms persist for more than seven days, discontinue use and consult physician

    keep out of reach of children. if swallowed, consult physician

    do not bandage tightly

  • INDICATIONS & USAGE

    for temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains and/or sprains.

  • DOSAGE & ADMINISTRATION

    apply directly to affected area. do not use more than four times per day.

  • PURPOSE

    for temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains and/or sprians.

  • PRINCIPAL DISPLAY PANEL

    carton label

  • INGREDIENTS AND APPEARANCE
    COLD SPOT  POINT RELIEF
    menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51452-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL14.4 mL  in 120 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE4.8 mL  in 120 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)  
    BROMELAINS (UNII: U182GP2CF3)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    Eucalyptus Globulus leaf (UNII: S546YLW6E6)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Dimethyl Sulfone (UNII: 9H4PO4Z4FT)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    alcohol (UNII: 3K9958V90M)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51452-005-044 mL in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34110/13/2011
    Labeler - Fabrication Enterprises, inc. (070577218)
    Registrant - Pure Source (969241041)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source 969241041manufacture
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