CAMPHOR, MENTHOL GEL [ACTIVE & INNOVATIVE INC.]

CAMPHOR, MENTHOL GEL [ACTIVE & INNOVATIVE INC.]
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NDC 50421-002-13
Set ID 0fb8495c-4fe6-49ad-a166-84303dd88642
Category HUMAN OTC DRUG LABEL
Packager Active & Innovative Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • 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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