DOCTRUST 2X TOOTH: Package Insert and Label Information

DOCTRUST 2X TOOTH- sodium fluoride paste
DONG IL PHARMS CO.,LTD

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.

Sodium Flouride

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

Brushing the teeth with a suitable amount

(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

For dental use only

DOCTRUST 2X TOOTH sodium fluoride paste

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73242-0100 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE 0.22 g in 100 g

Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL ACETATE SILICON DIOXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:73242-0100-1 100 g in 1 TUBE None

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	Operations
DONG IL PHARMS CO., LTD.		557810721	manufacture (73242-0100)

Revised: 11/2019 DONG IL PHARMS CO.,LTD