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.
Updated November 14, 2019
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- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
(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.
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
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
DOCTRUST 2X TOOTH
sodium fluoride paste
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73242-0100 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE 0.22 g in 100 g Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73242-0100-1 100 g in 1 TUBE; Type 0: Not a Combination Product 11/14/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 11/14/2019 Labeler - DONG IL PHARMS CO.,LTD (557810721) Registrant - DONG IL PHARMS CO.,LTD (557810721) Establishment Name Address ID/FEI Business Operations DONG IL PHARMS CO., LTD. 557810721 manufacture(73242-0100)