Label: TOOTH NOTE MOISTURIZING THERAPY TOOTH LEMON BASIL- dental type silica, tocopheryl acetate 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 February 23, 2021

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  • ACTIVE INGREDIENT

    Dental Type Silica, Tocopheryl Acetate

  • INACTIVE INGREDIENT

    L-menthol, Glycerin, Other Salts, Lauroyl Amidopropyldi-methylglycine solution, Centella asiatica extract, Potassium Acesulfame, Aloe barbadensis leaf extract, Xylitol, Citrusaurantium dulcis (Orange) oil, Purified water, Calendula officinalis extract, Cellulose gum, Chamomilla recutita (Matricaria) leaf extract, Sodium bicarbonate, Flavor, Sodium hyaluronate

  • PURPOSE

    Helps protect against cavities

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Brush the teeth with an appropriate amount of toothpaste.

  • WARNINGS

    1) Be careful not to swallow, and rinse mouth thoroughly after use
    2) If the use of toothpaste causes abnormalities such as gums or mouth injuries, discontinue use and consult a doctor or dentist
    3) If you are a child under 6 years of age, use a small amount of toothpaste as small as pea per use, and use under the supervision of a guardian to avoid sucking or swallowing
    4 If a child under 6 years of age swallowed large quantities, consult a physician or dentist immediately
    5) Keep out of the reach of children under 6 years

  • DOSAGE & ADMINISTRATION

    For dental use only

  • PRINCIPAL DISPLAY PANEL

    12

  • INGREDIENTS AND APPEARANCE
    TOOTH NOTE MOISTURIZING THERAPY TOOTH LEMON BASIL 
    dental type silica, tocopheryl acetate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81581-0001
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE20 g  in 100 g
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    WATER (UNII: 059QF0KO0R)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81581-0001-1150 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 - GI BILLIONS Co.,Ltd. (695631555)
    Registrant - GI BILLIONS Co.,Ltd. (695631555)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biostech Co., Ltd. 687294330manufacture(81581-0001)
    Establishment
    NameAddressID/FEIBusiness Operations
    GI BILLIONS Co.,Ltd. 695631555label(81581-0001)