Label: HEA YANTOOTHPASTE- precipitated calcium carbonate, aluminum chlorohydroxy allantoinate, aminocaproic acid, dibasic calcium phosphate hydrate 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 April 23, 2023

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  • ACTIVE INGREDIENT

    Precipitated Calcium Carbonate
    Aluminum Chlorohydroxy Allantoinate
    Aminocaproic Acid
    Dibasic Calcium Phosphate Hydrate

  • PURPOSE

    To be white and strong, Maintain and clean the mouth, Refresh the oral cavity, Prevention of tooth decay, eliminates bad breat, Enhances the aesthetic effect, Periodontitis (pyorrhea) the prevention, gum disease prevention, Prevention of gingivitis, periodontal disease prevention, gingiva diseage prevention, plaque removal (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

    D-Sorbitol Solution
    Glycerin
    Silica
    Roasted salt
    Xanthan Gum
    Carboxymethylcellulose Sodium
    Sodium Lauryl Sulfate
    Graperuit seed extract
    Sodium Saccharin
    xylitol
    L-Menthol
    Green tea extract
    Propolis Extract
    Glycyrrhiza Extract
    Mulberry Root Extract
    Peppermint oil
    Purified Water in Bulk

  • DOSAGE & ADMINISTRATION

    For dental use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HEA YANTOOTHPASTE 
    precipitated calcium carbonate, aluminum chlorohydroxy allantoinate, aminocaproic acid, dibasic calcium phosphate hydrate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73065-0008
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206) AMINOCAPROIC ACID0.09 g  in 100 g
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CARBONATE37 g  in 100 g
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) (ANHYDROUS DIBASIC CALCIUM PHOSPHATE - UNII:L11K75P92J) DIBASIC CALCIUM PHOSPHATE DIHYDRATE0.09 g  in 100 g
    ALCLOXA (UNII: 18B8O9DQA2) (ALCLOXA - UNII:18B8O9DQA2) ALCLOXA0.09 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73065-0008-1130 g in 1 TUBE; Type 0: Not a Combination Product04/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/24/2023
    Labeler - WOORI LIFE & HEALTH (694860803)
    Registrant - WOORI LIFE & HEALTH (694860803)
    Establishment
    NameAddressID/FEIBusiness Operations
    WOORI LIFE & HEALTH694860803manufacture(73065-0008) , label(73065-0008)