Label: PAIN RELIEFROLL ON ROLL ON- methyl salicylate mentol camphor capsaicin liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 10, 2010

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  • Active Ingredients

    Methyl Salicylate 30% .......….......… Topical Analgesic
    Menthol 10% ...……......……….....… Topical Analgesic
    Camphor 4% .……..…….............….. Topical Analgesic
    Capsaicin 0.03% .……..…….............Topical Analgesic

  • Uses

    ■ Temporarily relieves the minor aches and pains of
    muscles and joints associated with: ■ arthritis
    ■ strains ■ bruises ■ sprains ■ backache

  • Warnings

    For external use only

    Do not use: ■ on wounds or damaged skin
    ■ with a heating pad ■ on a child under 12 years of
    age with arthritis like conditions

  • Directions

    Directions
    ■ Use only as directed
    ■ Adults and children 12 years of age and older apply
    to affected area not more than 3 to 4 times daily
    ■ Children under 12 years of age ask a doctor

  • Inactive ingredients

    Inactive ingredients
    Water, PEG-8, Sodium Polyacrylate (and) Dimethicone (and) Cyclopentasiloxane (and) Trideceth-6 (and) PEG/PPG-18 Dimethicone, Glucosamine Hydrochloride, Petrolatum, Propylene Glycol, Beeswax, MSM, Phenoxyethanol

  • Questions?

    Questions? Call 1-305-785-6161

  • PRINCIPAL DISPLAY PANEL

    image of roll on label

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEFROLL ON   ROLL ON
    methyl salicylate mentol camphor capsaicin liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Methyl Salicylate (UNII: LAV5U5022Y) (Methyl Salicylate - UNII:LAV5U5022Y) Methyl Salicylate21 g  in 70 g
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol7 g  in 70 g
    CAMPHOR, (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR, (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR, (SYNTHETIC)2.8 g  in 70 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Polyethylene Glycol 400 (UNII: B697894SGQ)  
    Glucosamine Hydrochloride (UNII: 750W5330FY)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Wax, Yellow (UNII: 2ZA36H0S2V)  
    Dimethyl Sulfone (UNII: 9H4PO4Z4FT)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Capsaicin (UNII: S07O44R1ZM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24488-002-3370 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/10/2010
    Labeler - Creations Garden Natural Products, Inc. (839471216)
    Registrant - Creations Garden Natural Products, Inc. (839471216)
    Establishment
    NameAddressID/FEIBusiness Operations
    Creations Garden Natural Products, Inc. 839471216manufacture
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