Label: DOCTRUST 2X TOOTH- sodium fluoride paste

  • NDC Code(s): 73242-0100-1
  • Packager: DONG IL PHARMS CO.,LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 14, 2019

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

  • ACTIVE INGREDIENT

    Sodium Flouride

  • PURPOSE

    Keep your teeth white and strong.
    Keep your mouth clean.
    Refresh the inside of the mouth.
    Prevents tooth decay and bad breath by fluoride
    Increase esthetic effect.
    Removal of plaque (anti-plaque)
    Prevention of gingivitis and periodontitis
    Periodontal Disease Prevention
    Prevention of gum disease

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • INDICATIONS & USAGE

    Brushing the teeth with a suitable amount

  • WARNINGS

    (1) Contains 1000ppm of fluoride.
    (2) Do not swallow and rinse mouth thoroughly after use
    (3) If you experience any problems with your gums or mouth during use,
    discontinue use and consult your doctor.
    (4) For children under 6 years of age, use small amounts of toothpaste. And
    use itunder the supervision of a guardian to avoid sucking or swallowing.
    (5) Consult a physician or dentist immediately if a child under 6 years old
    hasswallowed large quantities.
    (6) Keep out of the reach of children under 6 years of age.

  • INACTIVE INGREDIENT

    Tocopherol Acetate, Silicon Dioxide, D-Sorbitol Solution, Carboxymethylcellulose Sodium, Chitosan, Propolis Extract, Glycyrrhiza Extract Powder, Ascorbic Acid, Green Tea Extract, Curcuma xanthorrhiza Extract, Xylitol, Enzymatically Modified Stevia, Sodium Cocoyl Glutamate, Sodium Bicarbonate, L-Menthol, Peppermint Oil, Water

  • DOSAGE & ADMINISTRATION

    For dental use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    DOCTRUST 2X TOOTH 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73242-0100
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.22 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73242-0100-1100 g in 1 TUBE; Type 0: Not a Combination Product11/14/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35511/14/2019
    Labeler - DONG IL PHARMS CO.,LTD (557810721)
    Registrant - DONG IL PHARMS CO.,LTD (557810721)
    Establishment
    NameAddressID/FEIBusiness Operations
    DONG IL PHARMS CO., LTD.557810721manufacture(73242-0100)