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

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

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 Label
Vontee toothpaste tablets (30tablets / 21g)
NDC: 80687-010-02

Image of carton

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

Image of carton

VONTEE 
silicon dioxide, tetrasodium pyrophosphate, pyridoxine hydrochloride, sodium flouride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80687-010
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE5.0 g  in 100 g
SODIUM PYROPHOSPHATE (UNII: O352864B8Z) (PYROPHOSPHORIC ACID - UNII:4E862E7GRQ) SODIUM PYROPHOSPHATE1.0 g  in 100 g
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE0.05 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.22 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
Xylitol (UNII: VCQ006KQ1E)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80687-010-021 in 1 CARTON10/01/2020
1NDC:80687-010-0121 g in 1 CONTAINER; Type 0: Not a Combination Product
2NDC:80687-010-041 in 1 CARTON10/01/2020
2NDC:80687-010-0370 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/01/2020
Labeler - VONJIL (695504176)
Registrant - VONJIL (695504176)
Establishment
NameAddressID/FEIBusiness Operations
Sungwon Pharmaceutical Co., Ltd.689787898manufacture(80687-010)

Revised: 10/2020
Document Id: 27b32b01-48cf-4892-8843-99689d5b4793
Set id: 334f29ea-a014-4a11-8c94-c26cec33be0f
Version: 5
Effective Time: 20201021
 
VONJIL