Label: CAMPHOR, 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 January 13, 2010

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  • Active Ingredients (% by weight)

    Camphor 4.0%

    Menthol 10.0%

  • Purpose

    Analgesic (pain relief)

  • Uses

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

  • Warnings

    • For external use only.
    • Caution: Discontinue use if excessive irritation of the skin develops. Avoid getting into eyes or on mucous membranes.
    • If the conditions worsens, or if the symptoms persists for more than 7 days or clears up and occurs again within a few days, discontinue use of this product and consult a doctor.
    • Do not apply to wounds or damaged skin. Do not bandage tightly.

    OTC - Keep Out of Reach of Children Section

    Keep out of reach of children.

    Other Warnings

    • Use only as directed.
    • Do not use if pregnant or breastfeeding.
    • If swallowed, get medical help or contact a poison Control center right away.
  • Directions

    Adults and children12 years of age or older: Using the roll on applicator massage a liberal amount of gel directly on the affected area not more than 3 or 4 times daily.
    Children under the age of 12: Do not use, consult a doctor.

  • Other Information

    Store under normal storage conditions. Store away from Children.

  • Inactive Ingredients

    Acrylates copolymer, boswellia, chondroitin sulphate, denatured alcohol, eucalyptus oil, glucosamine sulphate, glycerin,ilex, magnesium chloride, methylsulfonylmethane (MSM), peppermint oil, propylene glycol,triethanolamine, water.

  • Questions?

    416-967-3746

  • Principal Display Panel

    PROFESSIONAL THERAPY                           EXTRA STRENGTH
                                                                         EXTRA FUERTE

    MuscleCare TM

    PAIN RELIEVING GEL/ GEL ALIVIANTE DEL DOLOR

                                       by/ por el Dr. Chris Oswald

    FOR MUSCLE
        & JOINT
         PAIN
        RELIEF

      PARA EL
    ALIVIO DEL
       DOLOR
    MUSCULAR Y
     ARTICULAR

    NET Wt. Peso. NETO
       85g (3OZ.)

    Distributed by: Muscle care products
    1st. Clair Avenue East, Suite 1001,
    Toronto, ON M4T 2V7

    Professional Therapy Muscle Care TM
    is a registered trademark of Active &
    Innovative Inc.

    MADE IN CANADA.

    Tiene alguna pregunta? Llame al
    415-967-3746

    Distribuido por: Muscle care products
    1st. Clair Avenue East, Suite 1001,
    Toronto, ON M4T 2V7

    Professional Therapy Muscle Care TM
    es una marca registrada de Active &
    Innovative Inc.

    FABRICADO EN CANADA

    www.muscleandback.com
    Musclecare Pain relieving gel
  • INGREDIENTS AND APPEARANCE
    CAMPHOR, MENTHOL 
    camphor, menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50421-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (UNII: 5TJD82A1ET) (CAMPHOR - UNII:5TJD82A1ET) CAMPHOR3.4 g  in 85 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8.5 g  in 85 g
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50421-002-1385 g in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34801/13/2010
    Labeler - Active & Innovative Inc. (206978079)
    Establishment
    NameAddressID/FEIBusiness Operations
    International Laboratories (Canada) Ltd.247010150manufacture
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