Label: DOCTRUST K TOOTH- silicon dioxide, sodium monofluorophosphate gel, dentifrice

  • NDC Code(s): 76670-0014-1, 76670-0014-2
  • Packager: DOCSMEDI OralBiome 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 5, 2023

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

  • ACTIVE INGREDIENT

    Silicon dioxide 16.0%
    Sodium monofluorophosphate 0.740%
    (Total Fluoride Content 977 ppm Approx.)

  • Inactive ingredients

    Carboxymethyl cellulose, D-sorbitol solution, Sodium Hydrogencarbonate, Enzymatically modified stevia, Xylitol, Hydroxyapatite, Turmeric root extract, Centellaasiatica extract, HouttuyniacordataThunberg extract, Green tea extract, Salvia officinalis(sage) extract, Eucalyptus extract, naturalaromatics(Lime, Green grape) Sodium cocoyl glutamate, Purified water

  • PURPOSE

    Anticavity Toothpaste

  • WARNINGS

    ■ When using this product, if irritation occurs discontinue use, Stop use and ask a dentist if
    ■ For children under 6 years of age, use small amounts of toothpaste.
    under the supervision of a guardian to avoid sucking or swallowing.
    ■ Consult a physician or dentist immediately if a child under 6 years old has swallowed large quantities.
    ■ Keep out of the reach of children under 6 years of age.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Uses

    ■ Helps protect against cavities

  • Directions

    ■ 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 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.

  • Other Information

    ■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light

  • Questions

    ■ https://docsmedi.kr
    ■ Tel: 82-031-922-2240, Fax: 82-43-883-2844

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton
  • INGREDIENTS AND APPEARANCE
    DOCTRUST K TOOTH 
    silicon dioxide, sodium monofluorophosphate gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76670-0014
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Silicon dioxide (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) Silicon dioxide16.0 g  in 100 g
    Sodium monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.74 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76670-0014-21 in 1 CARTON12/01/2022
    1NDC:76670-0014-160 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/01/2022
    Labeler - DOCSMEDI OralBiome Co., Ltd. (694505169)
    Registrant - DOCSMEDI OralBiome Co., Ltd. (694505169)
    Establishment
    NameAddressID/FEIBusiness Operations
    DONG IL PHARMS CO., LTD.557810721manufacture(76670-0014)