Label: PAIN RELIEVING- camphor menthol methyl salicylate cream

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

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Drug Label Information

Updated March 31, 2010

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  • ACTIVE INGREDIENT

    Camphor 4% .……..…….............….. Topical Analgesic
    Menthol 10% ...……......……….....… Topical Analgesic
    Methyl Salicylate 30% .......….......… 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, carbomer, disodium edta, glyceryl stearate se,
    lanolin, polysorbate 80, stearic acid, triethanolamine,
    potassium hydroxide

  • Questions?

    Questions? Call 1-866-923-4914

  • PRINCIPAL DISPLAY PANEL

    image of tube label

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING   ULTRA STRENGTH
    camphor menthol methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)2.28 g  in 57 g
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol5.7 g  in 57 g
    Methyl Salicylate (UNII: LAV5U5022Y) (Methyl Salicylate - UNII:LAV5U5022Y) Methyl Salicylate9 g  in 57 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Carbomer Homopolymer Type C (UNII: 4Q93RCW27E)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Lanolin (UNII: 7EV65EAW6H)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Trolamine (UNII: 9O3K93S3TK)  
    Potassium Hydroxide (UNII: WZH3C48M4T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24488-001-331 in 1 CARTON
    157 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/31/2010
    Labeler - Creation's Garden Natural Products, Inc (839471216)
    Registrant - Creation's Garden Natural Products, Inc (839471216)
    Establishment
    NameAddressID/FEIBusiness Operations
    Creation's Garden Natural Products, Inc839471216manufacture
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