VONTEE- silicon dioxide, tetrasodium pyrophosphate, pyridoxine hydrochloride, sodium flouride tablet

Vontee by

Drug Labeling and Warnings

Vontee by is a Otc medication manufactured, distributed, or labeled by VONJIL, Sungwon Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

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

INACTIVE INGREDIENTS

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

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

WARNINGS

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

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

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

Directions

■ 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

■ 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

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

Package LabelVontee toothpaste tablets (30tablets / 21g)NDC:

80687-010-02

Package LabelVontee toothpaste tablets (100tablets / 70g)NDC:

80687-010-04

INGREDIENTS AND APPEARANCE

VONTEE 
silicon dioxide, tetrasodium pyrophosphate, pyridoxine hydrochloride, sodium flouride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80687-010
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	5.0 g  in 100 g
SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ)	SODIUM PYROPHOSPHATE	1.0 g  in 100 g
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	0.05 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.22 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
Xylitol (UNII: VCQ006KQ1E)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor	SPEARMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80687-010-02	1 in 1 CARTON	10/01/2020
1	NDC: 80687-010-01	21 g in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 80687-010-04	1 in 1 CARTON	10/01/2020
2	NDC: 80687-010-03	70 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/01/2020

Labeler - VONJIL (695504176)

Registrant - VONJIL (695504176)

Establishment
Name	Address	ID/FEI	Business Operations
Sungwon Pharmaceutical Co., Ltd.		689787898	manufacture(80687-010)