Label: TRIPLE POWER PAIN RELIEF (menthol, unspecified form and camphor- synthetic 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 June 30, 2015

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient Purpose
    Menthol 12% Pain Relieving
    Camphor 6%Pain Relieving
  • Uses

    for the temporary relief of minor aches and pains of muscles and joints associated with

    • simple backache
    • arthritis
    • strains
    • sprains
  • Warnings

    For external use only.

    • do not apply to wounds or damaged skin
    • do not bandage tightly
    • do not use with heating pad, pack, wrap, hot water bottle or any heating element

    When using this product do not get into eyes

    • avoid contact with other mucous membranes

    Extremely Flammable: Keep from heat and flame.

    Discontinue use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

    Keep out of reach of children.

    • if swallowed, get medical help or contact a Poison Control center right away
    • if pregnant or nursing, seek the advice of a health professional before using
  • Directions

    • Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock
    • Children under 12 years of age consult a physician
    • Apply a thin layer to affected area not more than 3 to 4 times daily
    • Gently massage into the skin until fully absorbed
    • Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes
  • Inactive ingredients

    Water (Aqua), Aloe Barbadensis Leaf Juice, SD Alcohol 40-B, Propylene Glycol, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Carbomer, Acrylates Copolymer, Corn Starch Modified, Linum Usitatissimum (Linseed) Seed Oil, Euterpe Oleracea Fruit Oil, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Lauryl Laurate, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch, Hydrolyzed Starch Octenylsuccinate, Phenoxyethanol (Phenagon PDI), DMDM Hydantoin, Iodopropynyl Butylcarbamate.

  • Questions or comments?

    Call 1-888-373-8831 or visit us at www.conceptlabs.org

  • PRINCIPAL DISPLAY PANEL - 106 g Bottle Label

    TRIPLE
    POWER
    PAIN RELIEF

    SUPER COOLING
    FAST ACTING

    MENTHOL & CAMPHOR

    +
    ARNICA,
    ROSEMARY
    & ACAI

    NET WT 3.75 OZ (106 g)

    Principal Display Panel - 106 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    TRIPLE POWER   PAIN RELIEF
    menthol, unspecified form and camphor (synthetic) cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-341
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.12 g  in 1 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.06 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ALCOHOL (UNII: 3K9958V90M)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    ACAI OIL (UNII: Z0W6766A2W)  
    PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)  
    METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
    ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    LAURYL LAURATE (UNII: GPW77G0937)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64058-341-64106 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34806/25/2015
    Labeler - Concept Laboratories, Inc. (962282612)
    Establishment
    NameAddressID/FEIBusiness Operations
    Concept Laboratories, Inc.962282612MANUFACTURE(64058-341)
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