Label: CAMPHOR, MENTHOL ointment

  • 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)

    Camphor4.0%
    Menthol 4.0%

  • 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.
    • 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 children 12 years of age or older: Rub this soothing cream on the affected area not more that 3 to 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

    Caprylyl glycol, cetyl alcohol, chondroitin sulphate, eucalyptus oil, glucosamine sulfate, glycerin, glycol stearate, grape seed oil, C13-14 isoparaffin, Laureth-7, lavender oil, methylsulfonyl-methane (MSM), phenoxyethanol, polyacrylamide, polysorbate-20, sea cucumber extract, sorbic acid, stearyl alcohol, thymol, urea, Vitamin E (tocopheral acetate), water, wintergreen oil.

  • Questions?

    Questions? 416-967-3746

  • Principal Display Panel

    PROFESSIONAL THERAPY        MAXIMUM STRENGTH

                                                      MAXIMA POTENCIA

    MuscleCare TM

    PAIN RELIEVING OINTMENT/ POMADA ALIVIANTE DEL DOLOR

                                                      by / por el Dr. Chris Oswald

        FOR
      MUSCLE
      & JOINT
    PAIN RELIEF

       PARA EL
      ALIVIO DEL
        DOLOR
    MUSCULAR Y
     ARTICULAR

    GREASELESS ●  STAINLESS ●  SHAKE WELL BEFORE EACH USE

    SIN GRASA ● NO MANCHA ● AGITAR BIEN ANTES DE CADA USO

    NET WT Peso NETO 115g. (4oz.)
    Musclecare Pain relieving ointment package
  • INGREDIENTS AND APPEARANCE
    CAMPHOR, MENTHOL 
    camphor, menthol ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50421-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (UNII: 5TJD82A1ET) (CAMPHOR - UNII:5TJD82A1ET) CAMPHOR4.6 g  in 115 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.6 g  in 115 g
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SORBIC ACID (UNII: X045WJ989B)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    THYMOL (UNII: 3J50XA376E)  
    UREA (UNII: 8W8T17847W)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    WATER (UNII: 059QF0KO0R)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50421-004-34115 g in 1 TUBE
    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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