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

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Colloidal Silicon Dioxide
Hydrogen Peroxide Solution 35 %
Tocopherol Acetate

For dental care

Keep out of reach of children

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

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.

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

For dental use only

1

DR.EL TOOTH WHITE TOOTH 
colloidal silicon dioxide, hydrogen peroxide, tocopherol acetate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72440-106
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE7 g  in 100 g
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL0.2 g  in 100 g
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE2.14 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
XYLITOL (UNII: VCQ006KQ1E)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72440-106-01120 g in 1 TUBE; Type 0: Not a Combination Product08/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/01/2019
Labeler - Dr. EL CO., LTD. (694771074)
Registrant - Dr. EL CO., LTD. (694771074)
Establishment
NameAddressID/FEIBusiness Operations
DONG IL PHARMS CO.,LTD557810721manufacture(72440-106)
Establishment
NameAddressID/FEIBusiness Operations
Dr. EL CO., LTD.694771074label(72440-106)

Revised: 9/2019
Document Id: 936ca241-2fe3-d094-e053-2a95a90ac307
Set id: 936ca241-2fe2-d094-e053-2a95a90ac307
Version: 1
Effective Time: 20190925
 
Dr. EL CO., LTD.