Label: KUNDAL PURE REFRESHING WHITENING TOOTH (SPEARMINT)- hydrogen peroxide, silicon dioxide paste

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

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Drug Label Information

Updated September 15, 2020

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  • ACTIVE INGREDIENT

    Hydrogen Peroxide, Konasil (Fumed Silica = Silicon Dioxide)

  • INACTIVE INGREDIENT

    Glycerin, PEG-32, Cellulose Gum, Xanthan Gum, Disodium Pyrophosphate, Salvia Officinalis (Sage) Leaf Extract, Eucalyptus Globulus Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extact, Camellia Sinensis Leaf Extract, Disodium EDTA, Xylitol, Stevioside, Sodium Benzotate, Sodium Cocoyl Glumate, Menthol, Cooling Fragrance, Spearmint Oil, Spearmint Flavor, Water

  • PURPOSE

    for dental care

  • 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 doctor.

    Children 2 to 6 years of age: Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

    Children under 2 years of age: Consult a dentist or doctor.

  • WARNINGS

    Do not swallow.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    For dental use only

  • PRINCIPAL DISPLAY PANEL

    11

  • INGREDIENTS AND APPEARANCE
    KUNDAL PURE REFRESHING WHITENING TOOTH (SPEARMINT) 
    hydrogen peroxide, silicon dioxide paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74773-0041
    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 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE7 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MENTHOL (UNII: L7T10EIP3A)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74773-0041-12 in 1 BOX09/01/2020
    1150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/01/2020
    Labeler - THESKINFACTORY Co., Ltd. (694804099)
    Registrant - THESKINFACTORY Co., Ltd. (694804099)
    Establishment
    NameAddressID/FEIBusiness Operations
    DONG IL PHARMS CO., LTD.557810721manufacture(74773-0041)
    Establishment
    NameAddressID/FEIBusiness Operations
    THESKINFACTORY Co., Ltd.694804099label(74773-0041)
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