Label: TOOTHPASTETOOTHPASTE (PINEAPPLE MINT FLAVOR)- hydrogen peroxide, tocopheryl acetate, silicon dioxide 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 May 2, 2023

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  • ACTIVE INGREDIENT

    Hydrogen peroxide, Tocopheryl acetate, silicon dioxide

  • 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

    Glycerin

    D-Sorbitol solution

    Propylene Glycol

    Xanthan gum

    Carboxymethyl cellulose sodium

    Sodium Cocoyl Glutamate

    Xylitol

    Steviol Glycoside

    Green tea extract

    Lycium Chinense Fruit Extract

    Mulberry Root Extract

    Angelica Gigas Root Extract

    Graperuit seed extract

    Mugwort Extract

    Aloe Extract(09)

    Mastic oil

    Sodium Phosphate

    Citric acid

    L-Menthol

    Spearmint flavor

    Peppermint oil

    Pineapple mint flavor

    Purified water

  • DOSAGE & ADMINISTRATION

    For dental use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    TOOTHPASTETOOTHPASTE (PINEAPPLE MINT FLAVOR) 
    hydrogen peroxide, tocopheryl acetate, silicon dioxide paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73065-0010
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE2.14 g  in 100 mL
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE0.2 g  in 100 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73065-0010-1100 mL 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(73065-0010) , label(73065-0010)