DENTI BOUNGIORNO ORIGINAL TOOTH- silica, sodium monofluorophosphate paste, dentifrice

DENTI BOUNGIORNO ORIGINAL TOOTH by

Drug Labeling and Warnings

DENTI BOUNGIORNO ORIGINAL TOOTH by is a Otc medication manufactured, distributed, or labeled by ATOSAFE CO., Ltd, DONG IL PHARMS CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient(s)

Silica 18.0%

Sodium Monofluorophosphate 0.76%

PURPOSE

Purpose

Antiplaque, Anticavity

WARNINGS

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.

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Use(s)

Fluoride content: 1,000 ppm

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

DOSAGE & 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 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

QUESTIONS

Questions

+82-1588-9709

INACTIVE INGREDIENT

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DENTI BOUNGIORNO ORIGINAL TOOTH 
silica, sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 85601-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	18 g  in 100 g
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 85601-010-02	1 in 1 CARTON	04/01/2025
1	NDC: 85601-010-01	100 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/01/2025

Labeler - ATOSAFE CO., Ltd (688995680)

Establishment
Name	Address	ID/FEI	Business Operations
DONG IL PHARMS CO., LTD.		557810721	manufacture(85601-010)