Label: VONTEE- silicon dioxide, tetrasodium pyrophosphate, pyridoxine hydrochloride, sodium flouride tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 80687-010-01, 80687-010-02, 80687-010-03, 80687-010-04 - Packager: VONJIL
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated October 21, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS
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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
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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
- Uses
- Directions
- Other Information
- QUESTIONS
- Package LabelVontee toothpaste tablets (30tablets / 21g)NDC: 80687-010-02
- Package LabelVontee toothpaste tablets (100tablets / 70g)NDC: 80687-010-04
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INGREDIENTS AND APPEARANCE
VONTEE
silicon dioxide, tetrasodium pyrophosphate, pyridoxine hydrochloride, sodium flouride tabletProduct 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)
