Label: MENTHOL, CAPSAICIN- vitacin patch

  • Category: HUMAN OTC DRUG LABEL

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 30, 2016

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  • ACTIVE INGREDIENTS

    Menthol 5%

  • PURPOSE

    External Analgesic

  • USES

    For the temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, sprains, bruises and strains.

  • WARNINGS

    • For external use only.
    • Use only as directed.
    • Avoid contact with eyes and mucous membranes.
    • Do not cover with bandage.
    • Do not use on wounds or damaged skin.
    • Do not use in combination with any other external analgesic products.
    • Do not use on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar device or garment.

    Keep out of reach of children

    Consult physician for children under 12.

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

    Pregnancy or Breast Feeding

    If pregnant or breast-feeding, ask a health professional before use.

  • DIRECTIONS

    • Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily.
    • Children under 12years, consult physician before use
    • Clean and dry affected area
    • Remove protective film and apply directly to area of pain
    • Apply to affected area not more than 3 times daily
    • Wash hands with soap after applying patch
    • Reseal pouch containing unused patches
  • INACTIVE INGREDIENTS

    WATER, GLYCERINE, SODIUM POLYACRYLATE, POLYSORBATE 80, ALOE BARBADESIS LEAF (ALOE VERA
    GEL) JUICE, EDTA DISODIUM SALT, DIAZOLIDINYL UREA, METHYLPARABEN, LODOPROYNYL BUTYLCABAMATE, PROPYLPARABEN.

  • Storage and Handling

    Store in dry area between 59-79 F(15-26 C)

  • Questions or Comments

    Please call (800) 768-3518

  • DOSAGE & ADMINISTRATION

    Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily.

    Children under 12years, consult physician before use.

  • VitaCin Patch

    Vitacin Patch

  • INGREDIENTS AND APPEARANCE
    MENTHOL, CAPSAICIN 
    vitacin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69677-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.375 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69677-011-1515 in 1 BOX09/01/2016
    18 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/01/2016
    Labeler - MAS Management Group Inc. (079363782)
    Establishment
    NameAddressID/FEIBusiness Operations
    MAS MANAGEMENT GROUP INC.079363782label(69677-011)
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