Label: HAE YAN TOOTH- precipitated calcium carbonate, aluminum chlorohydroxy allantoinate, aminocaproic acid, dibasic calcium phosphate hydrate paste

  • Category: HUMAN OTC DRUG LABEL

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 May 29, 2020

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  • ACTIVE INGREDIENT

    precipitated calcium carbonate, aminocaproic acid, aluminium chlorohydrin allantoinate, dibasic calcium phosphate hydrate

  • INACTIVE INGREDIENT

    d-sorbitol solution, glycerin, silica, roasted salt, xanthan gum, carboxymethylcellulose sodium, sodium lauryl sulfate, grapefruit seed extract, sodium saccharin, xylitol, l-menthol, green tea extract, propolis extract, glycyrrhiza extract, mulberry root extract, peppermint oil, purified water

  • PURPOSE

    aids in the prevention of dental cavities.

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    • Adults and children 2 years of age and older

    Brush teeth thoroughly preferably after each meal or at least twice a day or as directed by a dentist or docter.

    • Children under 6 years

    To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established.

    • Children under 2 years

    Consult a dentist or doctor

  • WARNINGS

    1) Be careful not to swallow it, and rinse your mouth thoroughly after use.

    2) If any abnormalities such as gum or mouth damage are caused by using this toothpaste, stop using the product and consult a doctor or dentist.

    3) For children under 6 years of age, use a small amount of pea toothpaste per serving and use it under the supervision of a guardian to avoid sucking or swallowing.

    4) If a child under 6 years of age swallows a large amount, consult a doctor or dentist immediately.

    5) Keep out of reach of children under 6 years old.

  • DOSAGE & ADMINISTRATION

    for external use only


  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HAE YAN TOOTH 
    precipitated calcium carbonate, aluminum chlorohydroxy allantoinate, aminocaproic acid, dibasic calcium phosphate hydrate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73065-0004
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206) AMINOCAPROIC ACID0.09 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
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION37 g  in 100 g
    ALCLOXA (UNII: 18B8O9DQA2) (ALCLOXA - UNII:18B8O9DQA2) ALCLOXA0.09 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73065-0004-1130 g in 1 TUBE; Type 0: Not a Combination Product05/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/25/2020
    Labeler - WOORILIFE&HEALTH (694860803)
    Registrant - WOORILIFE&HEALTH (694860803)
    Establishment
    NameAddressID/FEIBusiness Operations
    WOORILIFE&HEALTH694860803manufacture(73065-0004)