28TAK CLAIR TOOTH- silicon dioxide, sodium monofluorophosphate paste, dentifrice

28TAK CLAIR TOOTH by

Drug Labeling and Warnings

28TAK CLAIR TOOTH by is a Otc medication manufactured, distributed, or labeled by ELMEDITEC CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: SILICON DIOXIDE 8.0%, SODIUM MONOFLUOROPHOSPHATE 0.22%

INACTIVE INGREDIENT

Inactive ingredients:

D-Sorbitol Solution, Water, Concentrated Glycerin, Xantangum, Sodium Cocoyl Glutamate, Raspberry Flavor, Black Current Flavor, Xylitol, Chitosan, Rosemary Extract, Matricaria Extract, Eucalyptus Extract, Sage Extract, Aloe Extract, Green Tea Extract, Ascorbic Acid, Tocopherol Acetate

PURPOSE

Purpose: Anticavity

WARNINGS

Warnings:

(1) Contains 290ppm 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 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 of age.

KEEP OUT OF REACH OF CHILDREN

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

Uses

Uses:

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

Directions

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

28TAK CLAIR TOOTH 
silicon dioxide, sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72440-020
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	4.8 g  in 60 g
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.13 g  in 60 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Xylitol (UNII: VCQ006KQ1E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72440-020-02	1 in 1 CARTON	07/01/2018
1	NDC: 72440-020-01	60 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
unapproved drug other		07/01/2018

Labeler - ELMEDITEC CO.,LTD (694771074)

Registrant - ELMEDITEC CO.,LTD (694771074)

Establishment
Name	Address	ID/FEI	Business Operations
ELMEDITEC CO.,LTD		694771074	manufacture(72440-020)