Label: PROFESSIONAL THERAPY MUSCLE CARE PAIN RELIEVING OINTMENT BY DR. CHRIS OSWALD- camphor, menthol 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 January 13, 2010

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  • PRINCIPAL DISPLAY PANEL

    PROFESSIONAL THERAPY                                 MAXIMUM STRENGTH


                                              MUSCLECARE


         PAIN RELIEVING OINTMENT                     by Dr. Chris Oswald


                            FOR MUSCLE AND JOINT PAIN RELIEF.

    GREASELESS        STAINLESS           SHAKE WELL BEFORE EACH USE




                                            NET Wt. 115G (4oz)
    image of  cream label



  • ACTIVE INGREDIENT

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

    Camphor 4.0%  .........Anagelsic (pain relief)                       Menthol 4.0%  ..........Anagelsic (pain relief)

  • INACTIVE INGREDIENT




    Caprylyl glycol, cetyl alcohol, chondroitin sulfate, eucalyptus oil, glucosamine sulfate, glycerin, glycol stearate, grape seed oil, C13-14 isoparaffin, laureth-7, lavender oil, methylsulfonylmethane (MSM), phenoxyethanol, polyacrylamide, polysorbate-20, sea cucumber extract, sorbic acid, stearyl alcohol, thymol urea, vitamin E (tochoperhol acetate), water, wintergreen oil
  • DESCRIPTION

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

  • WARNINGS

    Warnings:

    For external use only.

    • 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.



  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

    • Use only as directed.
    • If swallowed, get medical help or contact a Poison Control center right away.
  • PREGNANCY OR BREAST FEEDING

    • Do not use if pregnant or breastfeeding
  • DOSAGE & ADMINISTRATION

    Adults and children 12 years of age or older:  Rub this soothing cream on the affected area not more than 3 to 4 times daily.

    Children under the age of 12:  Do not use, consult a doctor.

  • 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 OINTMENT BY DR. CHRIS OSWALD   MAXIMUM STRENGTH
    camphor, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49795-417
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Camphor (UNII: 5TJD82A1ET) (Camphor - UNII:5TJD82A1ET) Camphor4 g  in  100 g
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol4 g  in  100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cetyl alcohol (UNII: 936JST6JCN)  
    Glycol stearate (UNII: 0324G66D0E)  
    Dimethyl sulfone (UNII: 9H4PO4Z4FT)  
    Glycerin (UNII: PDC6A3C0OX)  
    Stearyl alcohol (UNII: 2KR89I4H1Y)  
    Glucosamine sulfate (UNII: 1FW7WLR731)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Urea (UNII: 8W8T17847W)  
    Eucalyptus oil (UNII: 2R04ONI662)  
    Vitamin E (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49795-417-04115 g in 1 TUBE
    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)