VITACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [MAS MANAGEMENT GROUP INC.]

VITACIN (METHYL SALICYLATE, MENTHOL, CAPSAICIN) CREAM [MAS MANAGEMENT GROUP INC.]
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NDC 69677-010-01
Set ID c8eda77c-2b0d-46f8-80a6-219f7b97e07d
Category HUMAN OTC DRUG LABEL
Packager MAS Management Group Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active Ingredient:

    Methyl Salicylate                     20.00%                                        Topical Analgesic

    Menthol                                    5.00%                                        Topical Analgesic

    Capsaicin                                  0.0375%                                    Topical Analgesic

  • PURPOSE

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, consult physician.

  • INDICATIONS & USAGE

    VitaCin

    (Capsaicin - Methyl Salicylate - Menthol)

  • DOSAGE & ADMINISTRATION

    Directions:

    • Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
    • Children under two-years of age: consult a physician.
  • WARNINGS

    Warnings:

    For external use only. 

    Avoid contact with eyes.

    If symptoms persist for more than seven days, discontinue use and consult physician.

    Do not apply to wounds or damaged skin.

    Do not bandage tightly.

    If pregnant or breast feeding, contact physician prior to use.

  • INACTIVE INGREDIENT

    Other Ingredients:

    aqua (deionized water), arnica montana flowe rextract, C13-14 isoparaffin, cetearyl alcohol, chondroitin sulfate, emu oil, ethylhexylglycerin, glucosamine sulfate, glycerin, glyceryl stearate, laureth-7, methylsulfonylmethane (MSM), PEG-100 stearate, phenoxyethanol, polyacrylamide, propylene glycol, stearic acid, triethanolamine, urea.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    VITACIN 
    methyl salicylate, menthol, capsaicin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69677-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE20 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0375 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHONDROITIN SULFATE (BOVINE) (UNII: 6IC1M3OG5Z)  
    EMU OIL (UNII: 344821WD61)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLUCOSAMINE SULFATE (UNII: 1FW7WLR731)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    LAURETH-7 (UNII: Z95S6G8201)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    UREA (UNII: 8W8T17847W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69677-010-01120 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/08/2015
    Labeler - MAS Management Group Inc. (079363782)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, Inc.969241041manufacture(69677-010)