Label: QUANTUMTOOTHCARE TOOTH- silicon dioxide, tocopherol acetate, tetrasodium pyrophosphate paste, dentifrice

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

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Drug Label Information

Updated March 4, 2021

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  • ACTIVE INGREDIENT

    Silicon Dioxide

    Tocopherol Acetate

    Tetrasodium Pyrophosphate

  • INACTIVE INGREDIENT

    D-Sorbitol Solution

    Concentrated Glycerin
    Carboxymethylcellulose Sodium

    Hydroxyapatite

    Medicinal Carbon

    Chitosan

    Mica

    Zeolite

    Xylitol

    Steviol Glycoside

    Papain

    Grapefruit Seed Extract

    L-Menthol

    Mentha Oil

    Propolis Extract

    Chamomile Extract

    Rosemary Extract

    Sage Extract

    Aloe Extract

    Glycyrrhiza Extract

    Horsetail Extract

    Lavender Oil

    Sodium Cocoyl Glutamate

    Lauroyl Amidopropyl Dimethyl Glycine Solution

    Deionized Water

  • PURPOSE

    For dental care

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Apply an appropriate amount to your toothbrush and brush your teeth by brushing.

  • WARNINGS

    Warnings

    Keep out of reach of children

    ■ If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

    Other Information

    ■ Store in an airtight container at room temperature

    ■ Date of use : 36 months from the date of manufacture

  • DOSAGE & ADMINISTRATION

    For dental use only

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    QUANTUMTOOTHCARE TOOTH 
    silicon dioxide, tocopherol acetate, tetrasodium pyrophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81659-0001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE14 g  in 100 g
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE0.1 g  in 100 g
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ) SODIUM PYROPHOSPHATE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    WATER (UNII: 059QF0KO0R)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81659-0001-1100 g in 1 TUBE; Type 0: Not a Combination Product02/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/01/2021
    Labeler - HealingStory.,LTD. (688403124)
    Registrant - HealingStory.,LTD. (688403124)
    Establishment
    NameAddressID/FEIBusiness Operations
    HealingStory.,LTD.688403124manufacture(81659-0001)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sungwon Pharmaceutical689787898manufacture(81659-0001)
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