Label: DR.EL TOOTH WHITE TOOTH- colloidal silicon dioxide, hydrogen peroxide, tocopherol acetate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 72440-106-01 - Packager: Dr. EL CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated September 25, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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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
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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
- DOSAGE & ADMINISTRATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DR.EL TOOTH WHITE TOOTH
colloidal silicon dioxide, hydrogen peroxide, tocopherol acetate paste, dentifriceProduct 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)
