Label: DR. DADDYS TOOTH- dental type silica, tetrasodium pyrophosphate paste, dentifrice

  • NDC Code(s): 76884-0003-1
  • Packager: TB Healthcare Co., Ltd.
  • 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 December 13, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Silicon Dioxide (Dental Type Silica), Sodium Pyrophosphate (Tetrasodium Pyrophosphate)

  • INACTIVE INGREDIENT

    D-Sorbitol Solution, Concentrated Glycerin, Xanthangum, Sodium Cocoyl Glutamate, Ascorbic Acid, Hydroxyapatite, Xylitol, Sodium Chloride, Green Tea Extract, Eucalyptus Extract, Matricaria Extract, Aloe Extract, Sage Extract, Grapefruit Seed Extract, Natural Strawberry Flavor, Water

  • PURPOSE

    ANTI-CAVITY

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Put an appropriate amount on a toothbrush and brush teeth.

  • WARNINGS

    Storage method

    1. Keep it at room temperature in a classified container.

    2. Cover and store at room temperature.

    3. Store in a not moisture and cool place.

    4. Air may come out during use of this product, but there is no problem with its weight.

    Usage Precautions

    1. Be careful not to swallow. Rinse mouth thoroughly after use

    2. If the use of toothpaste causes abnormalities such as gums or mouth injury, discontinue use and consult a doctor or dentist.

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

    4. If a child under 6 years old swallows large amount, consult with a doctor or dentist immediately.

    5. Keep out of the reach of children under 6 years of age.

  • DOSAGE & ADMINISTRATION

    For dental use only

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    DR. DADDYS TOOTH 
    dental type silica, tetrasodium pyrophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76884-0003
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE14 g  in 100 g
    SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ) SODIUM PYROPHOSPHATE0.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76884-0003-160 g in 1 TUBE; Type 0: Not a Combination Product12/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/01/2020
    Labeler - TB Healthcare Co., Ltd. (695035143)
    Registrant - TB Healthcare Co., Ltd. (695035143)
    Establishment
    NameAddressID/FEIBusiness Operations
    TB Healthcare Co., Ltd.695035143label(76884-0003)
    Establishment
    NameAddressID/FEIBusiness Operations
    K.Boeun Pharmaceutical Co.,Ltd.695674074manufacture(76884-0003)