83778-010

83778-010
SPL v1
SPL
SPL Set ID 2ef48156-904d-e42a-e063-6394a90a3cd0
Route
TOPICAL
Published
Effective Date 2025-02-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.25 g) Gluconic Acid (0.1 g)
Inactive Ingredients
Benzoic Acid Pentylene Glycol Zinc Lactate Methyl Diisopropyl Propionamide Caprylyl Glycol Sorbitol Disodium Phosphate Sodium Lauroyl Sarcosinate Calcium Glycerophosphate Carboxymethylcellulose Sodium, Unspecified Form Glycerin Water Hydrated Silica Xanthan Gum Sucralose Tetrapotassium Pyrophosphate Xylitol Benzyl Alcohol Menthol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-24

Description

Teeth cleaning

Purpose

Teeth cleaning


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


Raw Label Data

All Sections (JSON)