Label: PROFESSIONAL THERAPY MUSCLECARE EXTRA STRENGTH- menthol, camphor gel

  • NDC Code(s): 70039-200-02
  • Packager: Active and Innovative Inc.
  • 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 August 3, 2021

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

  • PURPOSE

    For Muscle and Joint Pain Relief

  • ACTIVE INGREDIENTS (% BY WEIGHT) PURPOSE

    Camphor 4.0%.................. Analgesic (pain relief)

    Menthol 10.0%...................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 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:

    Use only as directed.

    Do not use if pregnant or breastfeeding.

    If swallowed, get medical help or contact a Poison Control center right away.

  • DOSAGE & ADMINISTRATION

    Directions: Adults and children 12 years of age or older: Using the roll-on applicator massage a liberal amount of gel directly onto 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

    Other Information: Store under normal storage conditions. Store away from children.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Peppermint leaf oil (Mentha piperita), Eucalyptus globus leaf oil, Dimethyl sulfone (MSM), Boswellia Carterii Extract, Ilex Paraguariensis (Mate) leaf extract, Glucosamine sulfate, Chondroitin sulfte, Magnesium chloride, Tocopherol (natural Vitamin E), Thymol crystals (5-methyl-2-(1-methylethyl)phenol), Water, Ethanol, Glycerin, UREA, Hydroxypropyl methylcellulose.

  • Professional Therapy MuscleCare Extra Strength Pain Relieving Gel by Dr. Chris Oswald

    Full Label

  • INGREDIENTS AND APPEARANCE
    PROFESSIONAL THERAPY MUSCLECARE  EXTRA STRENGTH
    menthol, camphor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70039-200
    Route of AdministrationCUTANEOUS, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 1 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    CHONDROITIN SULFATE (CHICKEN) (UNII: 7VZ9466BAB)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    THYMOL (UNII: 3J50XA376E)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    UREA (UNII: 8W8T17847W)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70039-200-0285 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product01/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2017
    Labeler - Active and Innovative Inc. (206978079)
    Establishment
    NameAddressID/FEIBusiness Operations
    Delta Pharma Inc.200161730manufacture(70039-200)
    Establishment
    NameAddressID/FEIBusiness Operations
    PureTek Corporation785961046manufacture(70039-200)