83778-011

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (0.25 g)

Inactive Ingredients

Hydroxyapatite Cellulose Gum Fragrance Peppermint Orc2000647 Glycerin Water Sucralose Calcium Disodium Edta Xylitol Tetrasodium Pyrophosphate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-10-20

Medication Information

Purpose

Teeth cleaning

Description

Teeth cleaning

Use

Those who want to clean and whiten their teeth.

Stop Use

If there is any discomfort, please stop using.

Warnings

Product is not intended for use by children. Do not swallow. Do not use in eye area.

Ask Doctor

If there is any discomfort, please consult a dentist immediately

Directions

1. Apply 2 pumps to a soft bristle toothbrush.

2. Gently brush it a circular motion for 2 minutes.

3. Expel excess and rinse mouth after use, do not swallow.

Do Not Use

Product is not intended for use by children.

When Using

Do not swallow. Do not use in eye area.

Active Ingredient

Sodium Fluoride

Sodium Gluconate

Other Information

please keep in dry and cool place

Inactive Ingredients

Aqua/Water、Sorbitol、Hydrated Silica、Xylitol、Glycerin、Aroma(Flavour)、Disodium Phosphate、Sodium Lauroyl Sarcosinate、Calcium Glycerophosphate、Cellulose Gum、Xanthan Gum、Tetrapotassium Pyrophosphate、Benzyl Alcohol、Caprylyl Glycol、Sucralose、Menthol、Pentylene Glycol、Zinc Lactate、Methyl Diisopropyl Propionamide、Benzoic Acid.

Principal Display Panel

Keep Oot of Reach of Children

keep out of reach of young children

Structured Label Content

Use

Those who want to clean and whiten their teeth.

Purpose

Teeth cleaning

Stop Use

If there is any discomfort, please stop using.

Warnings

Product is not intended for use by children. Do not swallow. Do not use in eye area.

Ask Doctor

If there is any discomfort, please consult a dentist immediately

Directions

1. Apply 2 pumps to a soft bristle toothbrush.

2. Gently brush it a circular motion for 2 minutes.

3. Expel excess and rinse mouth after use, do not swallow.

Do Not Use (Do not use)

Product is not intended for use by children.

When Using

Do not swallow. Do not use in eye area.

Active Ingredient

Sodium Fluoride

Sodium Gluconate

Other Information (Other information)

please keep in dry and cool place

Inactive Ingredients (Inactive ingredients)

Aqua/Water、Sorbitol、Hydrated Silica、Xylitol、Glycerin、Aroma(Flavour)、Disodium Phosphate、Sodium Lauroyl Sarcosinate、Calcium Glycerophosphate、Cellulose Gum、Xanthan Gum、Tetrapotassium Pyrophosphate、Benzyl Alcohol、Caprylyl Glycol、Sucralose、Menthol、Pentylene Glycol、Zinc Lactate、Methyl Diisopropyl Propionamide、Benzoic Acid.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

keep out of reach of young children

Advanced Ingredient Data

[{"name": "HYDROXYAPATITE", "unii": "91D9GV0Z28", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE GUM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FRAGRANCE PEPPERMINT ORC2000647", "unii": "UHZ8T78D8B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM DISODIUM EDTA", "unii": "8U5D034955", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XYLITOL", "unii": "VCQ006KQ1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIB", "strengthNumerator": "0.25", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "TETRASODIUM PYROPHOSPHATE", "unii": "O352864B8Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "Those who want to clean and whiten their teeth.", "Purpose": "Teeth cleaning", "Stop Use": "If there is any discomfort, please stop using.", "Warnings": "Product is not intended for use by children. Do not swallow. Do not use in eye area.", "Ask Doctor": "If there is any discomfort, please consult a dentist immediately", "Directions": "1. Apply 2 pumps to a soft bristle toothbrush. 2. Gently brush it a circular motion for 2 minutes. 3. Expel excess and rinse mouth after use, do not swallow.", "Do not use": "Product is not intended for use by children.", "When Using": "Do not swallow. Do not use in eye area.", "Active Ingredient": "Sodium Fluoride Sodium Gluconate", "Other information": "please keep in dry and cool place", "Inactive ingredients": "Aqua/Water、Sorbitol、Hydrated Silica、Xylitol、Glycerin、Aroma(Flavour)、Disodium Phosphate、Sodium Lauroyl Sarcosinate、Calcium Glycerophosphate、Cellulose Gum、Xanthan Gum、Tetrapotassium Pyrophosphate、Benzyl Alcohol、Caprylyl Glycol、Sucralose、Menthol、Pentylene Glycol、Zinc Lactate、Methyl Diisopropyl Propionamide、Benzoic Acid.", "Keep Oot Of Reach Of Children": "keep out of reach of young children"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information