Label: APPATOTTOOTHPASTE- precipitated calcium carbonate paste, dentifrice

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

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Drug Label Information

Updated January 16, 2024

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  • ACTIVE INGREDIENT

    Calcium Carbonate

  • PURPOSE

    Tooth whitening, tooth decay prevention, bad breath removal. Makes tooth strong.

    Keeps the mouth clean, Refreshes the inside of the mouth. lncreases the aesthetic effect. Prevention of periodontal disease, gum disease and, removal of plaque (anti-plaque)

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    apply appropriate amount of the tooth paste on the tooth brush and brush the teeth

  • WARNINGS

    (1) Do not swallow, gargle fully after using.
    (2) If the use of this paste causes gingiva or oral cavity injury, please stop using and consult a doctor or a dentist.
    (3) If childern under 6 years of age use, please apply a pea-sized amount each thime. Do not swallow. Please use under the guidance of the guardian.
    (4) If children under 6 years of age accidentally ingest large amounts of the paste, please consult a doctor or a dentist immediately.
    (5) Keep out of reach of children under 6 years of age.

  • INACTIVE INGREDIENT

    Tocopheryl Acetate
    Aluminum Chlorohydroxy Allantoinate
    Dibasic Calcium Phosphate Hydrate
    D-Sorbitol Solution
    Glycerin
    Silica
    Carboxymethylcellulose Sodium
    Chitosan
    Cocamidopropyl Betaine
    Steviol Glycoside
    Xylitol
    L-Menthol
    Aloe Extract(09)
    Grapefruit Seed Extract
    Green Tea Extract
    Glycyrrhiza Extract
    Morinda Citrifolia Extract
    Sage Extract
    Propolis Extract
    Lemon oil
    Peppermint Oil
    Pine fravor
    Activated carbon
    Hydroxyapatite
    Purified Water in Bulk

  • DOSAGE & ADMINISTRATION

    For dental use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    APPATOTTOOTHPASTE 
    precipitated calcium carbonate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73065-0011
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    XYLITOL (UNII: VCQ006KQ1E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73065-0011-1180 g in 1 TUBE; Type 0: Not a Combination Product01/17/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/17/2024
    Labeler - WOORI LIFE & HEALTH (694860803)
    Registrant - WOORI LIFE & HEALTH (694860803)
    Establishment
    NameAddressID/FEIBusiness Operations
    WOORI LIFE & HEALTH694860803manufacture(73065-0011) , label(73065-0011)
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