28TAK DOUX TOOTH

Manufacturer
ELMEDITEC CO.,LTD
Effective date
2018-07-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:18

Label at a glance#

Product28TAK DOUX TOOTH
Active ingredientSILICON DIOXIDE
Label structure8 sections

Indications and 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)

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: SILICON DIOXIDE 8.0%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Purpose: Anticavity

WARNINGS

WARNINGS SECTION

Warnings:

(1) Do not swallow and rinse mouth thoroughly after use (2) If you experience any problems with your gums or mouth during use, discontinue use and consult your doctor. (3) 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. (4) Consult a physician or dentist immediately if a child under 6 years old has swallowed large quantities. (5) Keep out of the reach of children under 6 years of age.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

Image of cartonImage of carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809296113997GTIN-13: 8809296113997
EAN-13: 8809296113997
GTIN storage (14 digits): 08809296113997
doux carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72440-010-022020-01-31C16284748780-19d75b9d0-62b6-f424-e053-dadaa90a57ce8a08af40-8f0c-434e-b5de-a26b2e2f57bd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72440-010-0128TAK DOUX TOOTH60 g in 1 TUBEPASTE, DENTIFRICE601
72440-010-0228TAK DOUX TOOTH1 in 1 CARTONPASTE, DENTIFRICE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72440-01028TAK DOUX TOOTH (SILICON DIOXIDE) PASTE, DENTIFRICE [ELMEDITEC CO.,LTD]1Legacy NDC, 2 package rows20180717_8a08af40-8f0c-434e-b5de-a26b2e2f57bd.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72440-01072440-010-01, 72440-010-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4ACTIB
Water059QF0KO0RIACT
XylitolVCQ006KQ1EIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
959c54f7-67b9-47ca-8fb3-b4fbd1a1df5b8a08af40-8f0c-434e-b5de-a26b2e2f57bd2018-07-17WarningsExact identifier
spl id: 959c54f7-67b9-47ca-8fb3-b4fbd1a1df5b
spl set id: 8a08af40-8f0c-434e-b5de-a26b2e2f57bd

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.