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Joint and Muscle Pain (BioZone Laboratories, Inc.)

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CREAM 85 g in 1 TUBE (55379-404-85) Label Information

Complete Joint and Muscle Pain Information

  • ACTIVE INGREDIENT

    Menthol (5%)


  • PURPOSE

    Topical Analgesic


  • Directions

    Provides penetrating temporary relief for minor pain in muscles and joints associated with:

    • Backache
    • Arthritis
    • Bruises
    • Sprains

  • Warnings

    • For external use only. Do not use with a heating pad.  Do not apply to wounds or damaged skin. Do not bandage tightly after use.
    • Avoid contact with eyes.
    • Discontinue use and consult a physician if condition worsens, or if symptoms persist more than 7 days, or clear up and occur again within a few days.
    • Keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.

  • Directions

    • Adults and children over the age of 2: Apply generously to affected area.  Massage well into painful area. Repeat as necessary, but not more than 3 to 4 times daily.
    • Children under the age of 2: Do not use; consult a physician.

  • Inactive Ingredients

    Water, Butylene Glycol, Prunus amygdalus dulcis (Sweet Almond) Oil, PEG-12 Glyceryl Distearate, Cetyl Alcohol, Glyceryl Stearate, Cyclomethicone, PEG-100 Stearate, Dimethicone, Aloe barbadensis Leaf Extract, Ehtylhexylglycerin, Carbomer, Caprylyl Glycol, Hexylene Glycol, Phenoxyethanol, Triethanolamine, Xanthan Gum.


  • PRINCIPAL DISPLAY PANEL

    Image: tube_shk10_1.jpg

    image of tube label



  • INGREDIENTS AND APPEARANCE
    JOINT AND MUSCLE PAIN 
    menthol cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55379-404
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 50 mg  in 1 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55379-404-85 85 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 07/15/2009
    Labeler - BioZone Laboratories, Inc. (555564293)