Label: QUANTUMTOOTHCARE TOOTH- silicon dioxide, tocopherol acetate, tetrasodium pyrophosphate 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 March 4, 2021

If you are a consumer or patient please visit this version.

  • 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)