Vontee

Manufacturer
VONJIL | Sungwon Pharmaceutical Co., Ltd.
Effective date
2020-10-21
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:32:11

Label at a glance#

ProductVontee
Active ingredientSILICON DIOXIDE, SODIUM PYROPHOSPHATE, PYRIDOXINE HYDROCHLORIDE, SODIUM FLUORIDE
Label structure11 sections

Indications and uses

■ Help to reduce tooth decay, teeth-whitening, and morning-breath. ■ Aid in preventing gingivitis, periodontitis, gum disease, and tartar deposition.

Dosage and administration

■ Adults and children 7yrs. older: Open the lid and take out one tablet. ■ Chew 1 tablet until the bubbles formed. Brush teeth thoroughly at least twice a day, or use as directed by a dentist or physician. ■ Do not swallow. ■ Children under 6 yrs.: not recommend for the ages.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Silicon Dioxide 5.00%
Tetrasodium Pyrophosphate 1.00%
Pyridoxine Hydrochloride 0.05%
Sodium Fluoride 0.22%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

D-sorbitol, microcrystalline cellulose, bamboo salt, xylitol, steviol glycosides, enzymatically modified stevia, xanthan gum, hydroxypropylcellulose, citric acid, sodium bicarbonate, magnesium stearate, L-menthol, Combined Flavor, Chitosan, Papain, Grape Seed extract, sodium ascorbate, Tocopherol Acetate

PURPOSE

OTC - PURPOSE SECTION

Teeth-whitening / anti-plague
Prevent tartar deposition
Prevent periodontitis
Prevent tooth decay

WARNINGS

WARNINGS SECTION

1. Do not use it for anything other than brushing teeth, and be careful not to swallow it.
2. Keep it away from the children under age 6.
3. If a child (under age of 6) swallowed a large dose, please contact the doctor or health professionals immediately.
4. Keep the lid closed tightly and dry.
5. Don’t change the bottle to a new container.
6. Keep it away from the pets.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep it away from the children under age 6.

If a child (under age of 6) swallowed a large dose, please contact the doctor or health professionals immediately.

Uses

INDICATIONS & USAGE SECTION

■ Help to reduce tooth decay, teeth-whitening, and morning-breath.
■ Aid in preventing gingivitis, periodontitis, gum disease, and tartar deposition.

Directions

DOSAGE & ADMINISTRATION SECTION

■ Adults and children 7yrs. older: Open the lid and take out one tablet.
■ Chew 1 tablet until the bubbles formed. Brush teeth thoroughly at least twice a day, or use as directed by a dentist or physician.
■ Do not swallow.
■ Children under 6 yrs.: not recommend for the ages.

Other Information

OTHER SAFETY INFORMATION

■ Keep away from direct sunlight and humid places.
■ Store in the cabinet where children can’t reach.
■ Do not mix with other medicines nor pour water into it.

QUESTIONS

OTC - QUESTIONS SECTION

website: www.vontee.co
phone: (+82) 1877 - 3027

Package LabelVontee toothpaste tablets (30tablets / 21g)NDC: 80687-010-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

Package LabelVontee toothpaste tablets (100tablets / 70g)NDC: 80687-010-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80687-010-022023-01-30C16284748780-1f386c64a-3552-0266-e053-dadaa90a7c1a334f29ea-a014-4a11-8c94-c26cec33be0f
80687-010-042023-01-30C16284748780-1f386c64a-3552-0266-e053-dadaa90a7c1a334f29ea-a014-4a11-8c94-c26cec33be0f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80687-010-01Vontee21 g in 1 CONTAINERTABLET215
80687-010-02Vontee1 in 1 CARTONTABLET15
80687-010-03Vontee70 g in 1 CONTAINERTABLET705
80687-010-04Vontee1 in 1 CARTONTABLET15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80687-010VONTEE (SILICON DIOXIDE, TETRASODIUM PYROPHOSPHATE, PYRIDOXINE HYDROCHLORIDE, SODIUM FLOURIDE) TABLET [VONJIL]5Legacy NDC, 4 package rows20201022_334f29ea-a014-4a11-8c94-c26cec33be0f.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80687-01080687-010-01, 80687-010-02, 80687-010-03, 80687-010-04

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
27b32b01-48cf-4892-8843-99689d5b4793334f29ea-a014-4a11-8c94-c26cec33be0f2020-10-21WarningsExact identifier
spl id: 27b32b01-48cf-4892-8843-99689d5b4793
spl set id: 334f29ea-a014-4a11-8c94-c26cec33be0f

Reported adverse events (FAERS/openFDA)#

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