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

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  • Active Ingredient (% by weight)

    Camphor 4.0%
    Menthol 4.0%
  • 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.

    • 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
  • Directions:

    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.

  • Other Information:

    Store under normal storage conditions. Store away from children.

  • Inactive Ingredients:

    Water/Aqua; Cetyl Alcohol, Glycol Stearate, MSM (Methylsulfonylmethane), Glycerin, Stearyl Alcohol, Glucosamine Sulfate, Polyacrylamide (and) C13-14 Isoparaffin (and) Laureth-7, Tocopheryl (Vitamain E) Acetate, Oil of Wintergreen (Methyl Salicylate), Cucumaria (Sea Cucumber) Frondosa, Grape Seed Oil, Urea, Phenoxyethanol (and) Caprylyl Glycol (and) Sorbic Acid, Polysorbate-20, Eucalyptus Globulus Leaf Oil, Thymol, Aloe Barbadensis Leaf Juice, Chondroitin Sulfate, Magnesium Chloride

  • Questions?/Tiene alguna pregunta?

    Llame al 416-967-3746

  • PRINCIPAL DISPLAY PANEL

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    usa_Max_ointmentMC_4oz_label

  • INGREDIENTS AND APPEARANCE
    MUSCLECARE  PROFESSIONAL THERAPY PAIN RELIEVING
    menthol and camphor ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-027
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL4.6 g  in 115 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)4.6 g  in 115 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)  
    ACRYLAMIDE (UNII: 20R035KLCI)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    LAURETH-7 (UNII: Z95S6G8201)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    CUCUMARIA FRONDOSA (UNII: 4M1271AZ6G)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    UREA (UNII: 8W8T17847W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SORBIC ACID (UNII: X045WJ989B)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    THYMOL (UNII: 3J50XA376E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SULFATE ION (UNII: 7IS9N8KPMG)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24488-027-08115 g in 1 TUBE
    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 Progess (961956229)
    Establishment
    NameAddressID/FEIBusiness Operations
    Creations Garden Natural Progess961956229manufacture
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