JOINT AND MUSCLE PAIN (MENTHOL) CREAM [BIOZONE LABORATORIES, INC.]

JOINT AND MUSCLE PAIN (MENTHOL) CREAM [BIOZONE LABORATORIES, INC.]
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NDC 55379-404-85
Set ID 8d0cb441-4cc9-4225-abd5-e034a6b834b8
Category HUMAN OTC DRUG LABEL
Packager BioZone Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:55379-404
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol50 mg  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55379-404-8585 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/15/2009
    Labeler - BioZone Laboratories, Inc. (555564293)

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