Label: DOCTRUST ONE S TOOTH- sodium fluoride, dental type silica, potassium nirate paste, dentifrice

  • NDC Code(s): 76670-0011-1, 76670-0011-2
  • 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

    Sodium fluoride 0.0221%
    (Total Fluoride Content 1,000 ppm Approx.)
    Dental type silica 17.50%
    Potassium nirate 5.00%

  • INACTIVE INGREDIENTS

    Sodium carboxymethyl cellulose, D-sorbitol solution, Concentrated glycerin, Xylitol, Enzymatically modified stevia, Hydroxyapatite, Taraxacum officinale extract, Turmeric root extract, Green tea extract, Calendula extract, Eucalyptus extract, Salvia officinalis (sage) extract, Aloe extract(09), L-menthol, Herb mint flavor, Cooling flavor, Menthol pulegium oil, Sodium lauroyl sarcosinate, Sodium cocoyl glutamate, Purified water

  • PURPOSE

    Anti plaque, Anticaries, Anticavity, Antihypersensitivity

  • 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

    ■ Builds increasing protection against painful sensitivity
    ■ Aids in the prevention of dental cavities.

  • Directions

    ■ Adults and children 12 years of age and older:
    • Apply at least 1-inch strip of the product onto a soft bristle toothbrush
    • Brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
    ■ Children under 12 years of age: 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 ONE S TOOTH 
    sodium fluoride, dental type silica, potassium nirate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76670-0011
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium fluoride (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 g  in 100 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE17.50 g  in 100 g
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5.00 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76670-0011-21 in 1 CARTON12/01/2021
    1NDC:76670-0011-1100 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/01/2021
    Labeler - DOCSMEDI OralBiome Co., Ltd. (694505169)
    Registrant - DOCSMEDI OralBiome Co., Ltd. (694505169)
    Establishment
    NameAddressID/FEIBusiness Operations
    DONG IL PHARMS CO., LTD.557810721manufacture(76670-0011)