Label: MUSCLECARE PROFESSIONAL THERAPY PAIN RELIEVING- camphor and 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 June 21, 2011

If you are a consumer or patient please visit this version.

  • Active Ingredients (% by weight)

    Camphor 4.0%

    Menthol 10.0%

  • Purpose

    Analgesic (Pain Relief)

    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 condition worsens, or if symptoms persist for more than 7 days or clear up and occur again with in a few days, discontinue use of this products and consult a doctor.
    • Do not apply to wounds or damaged skin. Do not bandage tightly.
  • 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.
  • Directions:

    Adults and children 12 years of age or older. Using the roll-on applicator, message a liberal amount of gel directly on the affected area not more than 3 to 4 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:

    Alcohol Denat, Acrylates Copolymer, Water, Eucalyptus Globulus Leaf Oil, Mentha Piperita (Peppermint) Oil, Propylene Glycol, Glycerin, MSM (Methylsulfonymethane), Boswellia Serrata Extract,  Glucosamine Sulfate, Chondroitin Sulfate, Magnesium Chloride, Triethanolamine

  • Questions?

    416-967-3746
  • PRINCIPAL DISPLAY PANEL

    Placeholder Text


    MuscleCare_Extra_Strength_Rollon_3oz

  • INGREDIENTS AND APPEARANCE
    MUSCLECARE  PROFESSIONAL THERAPY PAIN RELIEVING
    camphor and menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-026
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL8.5 g  in 85 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.4 g  in 85 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    POLYACRYLIC ACID (800000 MW) (UNII: D0I6NSZ87U)  
    WATER (UNII: 059QF0KO0R)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    SULFATE ION (UNII: 7IS9N8KPMG)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24488-026-0785 g in 1 BOTTLE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34106/21/2011
    Labeler - Active and Innovative (961956229)
    Registrant - Creations Garden Natural Products (961956229)
    Establishment
    NameAddressID/FEIBusiness Operations
    Creations Garden Natural Products961956229manufacture