DENTI BOUNGIORNO ORIGINAL TOOTH

Manufacturer
ATOSAFE CO., Ltd | DONG IL PHARMS CO., LTD.
Effective date
2025-05-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:00:33

Label at a glance#

ProductDENTI BOUNGIORNO ORIGINAL TOOTH
Active ingredientSILICON DIOXIDE, SODIUM MONOFLUOROPHOSPHATE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient(s)

Silica 18.0%

Sodium Monofluorophosphate 0.76%

OTC - PURPOSE SECTION

Purpose

Antiplaque, Anticavity

WARNINGS SECTION

Warnings

• Keep out of reach of children under 6 years of age.
• If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

Use(s)

• Fluoride content: 1,000 ppm

• Removes plaque (anti-plaque)
• Helps reduce bad breath by controlling oral bacteria

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 brushing and rinsing (to minimize swallowing).
• Children under 2 years: Ask a dentist or physician.

OTHER SAFETY INFORMATION

Other Information

• Store at temperatures between 1°C and 30°C
• Use within 36 months from the date of manufacture
• Do not store in high/low temperatures or direct sunlight

OTC - QUESTIONS SECTION

Questions

+82-1588-9709

INACTIVE INGREDIENT SECTION

Inactive ingredients

Sorbitol, Water, Glycerin, Sodium Cocoyl Glutamate, PEG-32, Cellulose Gum, Herb Mint Flavor, Menthol, Stevioside, Sodium Methyl Cocoyl Taurate, Mint Flavor, Sodium Bicarbonate, Titanium Dioxide, Xylitol, Propolis Wax, Chamomilla Recutita Flower Extract, Salvia Officinalis Leaf Extract, Camellia Sinensis Leaf Extract, Citrus Paradisi Fruit Extract, Centella Asiatica Extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton ImageCarton Image

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85601-010DENTI BOUNGIORNO ORIGINAL TOOTH (SILICA, SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ATOSAFE CO., LTD]1Unmatched20250508_3487b2db-5f78-625f-e063-6294a90a0c8c.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85601-01085601-010-01, 85601-010-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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
4114f9ab-6620-cca8-e063-6394a90ae4bd3487b2db-5f78-625f-e063-6294a90a0c8c2025-10-13WarningsExact identifier
spl set id: 3487b2db-5f78-625f-e063-6294a90a0c8c

Reported adverse events (FAERS/openFDA)#

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