Dr.EL CLAIR TOOTH

Manufacturer
Dr. EL CO., LTD. | DONG IL PHARMS CO.,LTD
Effective date
2019-09-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:09:47

Label at a glance#

ProductDr.EL CLAIR TOOTH
Active ingredientSODIUM MONOFLUOROPHOSPHATE, SILICON DIOXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

SILICON DIOXIDE, SODIUM MONOFLUOROPHOSPHATE

OTC - PURPOSE SECTION

For dental care

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

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 SECTION

(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.

INACTIVE INGREDIENT SECTION

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

DOSAGE & ADMINISTRATION SECTION

For dental use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72440-104-012025-01-03C16284748780-1f386c64a-4795-0266-e053-dadaa90a7c1a935b98bc-fd37-9348-e053-2a95a90a1395
72440-104-012023-01-30C16284748780-1f386c64a-4795-0266-e053-dadaa90a7c1a935b98bc-fd37-9348-e053-2a95a90a1395

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72440-10472440-104-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

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
2ac81746-139d-68c7-e063-6294a90abf92935b98bc-fd37-9348-e053-2a95a90a13952025-01-03WarningsExact identifier
spl set id: 935b98bc-fd37-9348-e053-2a95a90a1395

Reported adverse events (FAERS/openFDA)#

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