MEDI I TOOTH- sodium monofluorophosphate paste, dentifrice

Medi i Tooth by

Drug Labeling and Warnings

Medi i Tooth by is a Otc medication manufactured, distributed, or labeled by MEDIF CO.,LTD, DONG IL PHARMS CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium Monofluorophosphate 0.38%

INACTIVE INGREDIENTS

Water, Sorbitol, Silica, Glycerin, Strawberry flavor, Xanthan gum, Sodium Cocoyl Glutamate, Xylitol, Stevioside, Camellia Sinensis Leaf Extract, Eucalyptus Globulus Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Aloe Barbadensis Leaf Extract, Matricaria Extract

PURPOSE

Anticarries

WARNINGS

1) This toothpaste contains 500ppm 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 it under the supervision of a guardian to avoid sucking or swallowing.

5) Consult a physician or dentist immediately if a child under 6 years old has swallowed large quantities.

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

KEEP OUT OF REACH OF CHILDREN

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

Uses

1) Keep your teeth white and strong.
2) Keep your mouth clean.
3) Refresh the inside of the mouth.
4) To prevent tooth decay and remove bad breath.
5) Increase esthetic effect.
6) Removal of plaque(anti-plaque).

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 physician
■ Children 2 to 6 years: Use only a pea-sized amount and supervise child’s brushing and rinsing (to minimize swallowing)
■ Children under 2 years: Ask a dentist or physician

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEDI I TOOTH 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72346-100
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.26 g  in 70 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Sorbitol (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72346-100-02	1 in 1 CARTON	08/01/2020
1	NDC: 72346-100-01	70 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/01/2020

Labeler - MEDIF CO.,LTD (694955391)

Registrant - MEDIF CO.,LTD (694955391)

Establishment
Name	Address	ID/FEI	Business Operations
DONG IL PHARMS CO.,LTD		557810721	manufacture(72346-100)