DR.EL TOOTH WHITE TOOTH- colloidal silicon dioxide, hydrogen peroxide, tocopherol acetate paste, dentifrice

Dr.EL TOOTH WHITE TOOTH by

Drug Labeling and Warnings

Dr.EL TOOTH WHITE TOOTH by is a Otc medication manufactured, distributed, or labeled by Dr. EL CO., LTD., DONG IL PHARMS CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Colloidal Silicon Dioxide
Hydrogen Peroxide Solution 35 %
Tocopherol Acetate

PURPOSE

For dental care

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

INDICATIONS & USAGE

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

WARNINGS

1. Application precautions

1)Do not use anything other than a brushing teeth.

2)If you've eaten too much of this product, Consult a physician or dentist immediately.

2. Cautions for storage

1)Keep out of the reach of children under of age and If used by children, And use itunder the supervision of a guardian.

2)Avoid direct sunlight and keep the lid at room temperature.

INACTIVE INGREDIENT

D-Sorbitol Solution, Carboxymethylcellulose Sodium, Aloe Extract, Chamomile Extract, Green Tea Extract, Xylitol, Erythritol, Hydroxyapatite, Eucalyptus Extract, Peppermint Oil, Mint Flavor, L-Menthol, Polysorbate 20, Sodium Cocoyl Glutamate, Aqua

DOSAGE & ADMINISTRATION

For dental use only

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR.EL TOOTH WHITE TOOTH 
colloidal silicon dioxide, hydrogen peroxide, tocopherol acetate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72440-106
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	7 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL	0.2 g  in 100 g
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	2.14 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
XYLITOL (UNII: VCQ006KQ1E)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72440-106-01	120 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/01/2019

Labeler - Dr. EL CO., LTD. (694771074)

Registrant - Dr. EL CO., LTD. (694771074)

Establishment
Name	Address	ID/FEI	Business Operations
DONG IL PHARMS CO.,LTD		557810721	manufacture(72440-106)

Establishment
Name	Address	ID/FEI	Business Operations
Dr. EL CO., LTD.		694771074	label(72440-106)