Label: PROFESSIONAL THERAPY MUSCLE CARE PAIN RELIEVING GEL BY DR. CHRIS OSWALD MAXIMUM STRENGTH- menthol, camphor gel

  • 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 January 18, 2010

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  • DOSAGE & ADMINISTRATION

    Adults and children 12 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 to 4 times daily.
    Children under the age of 12:  Do not use, consult a doctor.
  • PRINCIPAL DISPLAY PANEL

    PROFESSIONAL THERAPY                      MAXIMUM STRENGTH


                                     MUSCLECARE


    PAIN RELIEVING GEL                            by Dr. Chris Oswald


                           FOR MUSCLE AND JOINT PAIN RELIEF.



                                        NET Wt. 85g (3oz)image of gel label


                            

  • WARNINGS AND PRECAUTIONS

    Warnings:

    For external use only.

    CAUTION: 

    • Discontinue use if excessive irritation of the skin develops. 
    • Avoid getting into eyes or on mucous membranes.
    • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur 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.
  • ACTIVE INGREDIENT

    Active Ingredients (% by weight)          Purpose                       Active Ingredients (% by weight)          Purpose

    Camphor 4.0 %.............Analgelsic (pain relief)                       Menthol 10.0 %.............Analgelsic (pain relief)

  • INACTIVE INGREDIENT

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

  • DESCRIPTION

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

    Store under normal storage conditions.  Store away from children

  • REFERENCES

    Questions? 416-967-3746                                             MADE IN CANADA

    Manufactured for  / ergo-health a division of Active and Innovative Inc.

    1 St. Clair Avenue East, Suite 1001, Toronto ON   M4T 2V7  ergo-health and Muscle Care are registered trademarks of ergo-health, a division of Active and Innovative Inc.    www.ergo-health.com

  • INGREDIENTS AND APPEARANCE
    PROFESSIONAL THERAPY MUSCLE CARE PAIN RELIEVING GEL BY DR. CHRIS OSWALD  MAXIMUM STRENGTH
    menthol, camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49795-416
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol10 g  in 100 g
    Camphor (UNII: 5TJD82A1ET) (Camphor - UNII:5TJD82A1ET) Camphor4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Eucalyptus oil (UNII: 2R04ONI662)  
    Peppermint oil (UNII: AV092KU4JH)  
    Propylene glycol (UNII: 6DC9Q167V3)  
    Glycerin (UNII: PDC6A3C0OX)  
    Dimethyl sulfone (UNII: 9H4PO4Z4FT)  
    Glucosamine sulfate (UNII: 1FW7WLR731)  
    Magnesium chloride (UNII: 02F3473H9O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49795-416-8585 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/15/2010
    Labeler - Nutri-Dyn Products Ltd. dba Professional Health Products (209901511)
    Registrant - Ergo-Health a division of Active & Innovative Inc. (206978079)
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