Label: CHUNZAM SILK AMINO ACID TOOTH- silicon dioxide, sodium monofluorophosphate, tocopherol acetate paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 26, 2017

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  • ACTIVE INGREDIENT

    Silicon Dioxide, Sodium Monofluorophosphate, Tocopherol acetate

  • INACTIVE INGREDIENT

    D-Sorbitol, Propolis Extract, ETC

  • PURPOSE

    For dental care

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    apply proper amount on your toothbrush, brush teeth

  • WARNINGS

    - do not swallow when using this product
    - if more than used for rinsing is accidentally swallowed, get medical helps or contact a poison control center right away

  • DOSAGE & ADMINISTRATION

    use when is needed

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    CHUNZAM SILK AMINO ACID TOOTH 
    silicon dioxide, sodium monofluorophosphate, tocopherol acetate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71078-0001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE0.1 g  in 100 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE4 g  in 100 g
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.33 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71078-0001-1150 g in 1 TUBE; Type 0: Not a Combination Product11/11/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/11/2016
    Labeler - CHUNZAM BIO CO LTD (693894411)
    Registrant - CHUNZAM BIO CO LTD (693894411)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd.688732723manufacture(71078-0001)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHUNZAM BIO CO LTD693894411label(71078-0001)