SPL v1
SPL
SPL Set ID 3fb153f1-ba6e-7251-e063-6294a90abe62
Route
ORAL
Published
Effective Date 2025-09-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.22 g)
Inactive Ingredients
Tribasic Calcium Phosphate Water Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-01

Description

Active ingredient(s) Sodium Fluoride 0.221%


Medication Information

Warnings and Precautions

Warnings

■ Do not do the following while using this products

Do not use it except for brushing teeth.

■ Other precautions to be taken when using non-medical products

1) The fluoride content of this toothpaste is 1,000 ppm (the total content must be 1,000 ppm or less).

2) If used by children under the age of six, use a small amount of toothpaste about the size of peas per use, and have it used under the guidance of a guardian to prevent washing or swallowing.

3) If a child under the age of 6 swallows a large amount, consult a doctor or dentist immediately.

■ Storage precautions

1) Store out of reach of children under the age of six.

2) Remove the non-drug from the original container and store it in another container, which can cause accidents or poor product quality due to misuse, so put it in the original container and keep it closed tightly.

Indications and Usage

Use(s)

■ Protection of sensitive teeth

■ Removal of plaque (anti-prag)

■ Prevention of Tooth decay by Fluoride

■ Keep your teeth white and strong

■ Keep your mouth clean

■ Refresh the inside of the mouth

■ Removes bad breath

■ Increases aesthetic effect

Dosage and Administration

Directions

■ Apply an appropriate amount to a toothbrush twice a day (morning and evening) and brush your teeth by brushing.

Description

Active ingredient(s) Sodium Fluoride 0.221%

Section 50565-1

If a child under the age of 6 swallows a large amount, consult a doctor or dentist immediately.

Section 51727-6

Inactive ingredients

Sorbitol, Hydrated Silica, Water, Hydroxyapatite, Potassium Nitrate, Glycerin, Cellulose Gum, Sodium Cocoyl Glutamate, Sodium Methyl Cocoyl Taurate, Xylitol, Menthol, Stevioside, Mentha Pulegium Oil, Mentha Piperita Oil, Cooling Flavor, Mint Flavor, Sodium Chloride, Clove Mint Flaovr, Tocopheryl Acetate, Eugenia Caryophyllus (Clove) Flower Oil, Salvia Officinalis Leaf Extract, Aloe Barbadensis Leaf Extract, Rosmarinus Officinalis Leaf Extract, Calendula Officinalis Flower Extract

Section 51945-4

Section 55105-1

Purpose

Anti-cavity

Section 55106-9

Active ingredient(s)

Sodium Fluoride 0.221%

Section 60561-8

Other Information

■ Airtight container, Store in room temperature (1~30℃)


Structured Label Content

Indications and Usage (34067-9)

Use(s)

■ Protection of sensitive teeth

■ Removal of plaque (anti-prag)

■ Prevention of Tooth decay by Fluoride

■ Keep your teeth white and strong

■ Keep your mouth clean

■ Refresh the inside of the mouth

■ Removes bad breath

■ Increases aesthetic effect

Dosage and Administration (34068-7)

Directions

■ Apply an appropriate amount to a toothbrush twice a day (morning and evening) and brush your teeth by brushing.

Warnings and Precautions (34071-1)

Warnings

■ Do not do the following while using this products

Do not use it except for brushing teeth.

■ Other precautions to be taken when using non-medical products

1) The fluoride content of this toothpaste is 1,000 ppm (the total content must be 1,000 ppm or less).

2) If used by children under the age of six, use a small amount of toothpaste about the size of peas per use, and have it used under the guidance of a guardian to prevent washing or swallowing.

3) If a child under the age of 6 swallows a large amount, consult a doctor or dentist immediately.

■ Storage precautions

1) Store out of reach of children under the age of six.

2) Remove the non-drug from the original container and store it in another container, which can cause accidents or poor product quality due to misuse, so put it in the original container and keep it closed tightly.

Section 50565-1 (50565-1)

If a child under the age of 6 swallows a large amount, consult a doctor or dentist immediately.

Section 51727-6 (51727-6)

Inactive ingredients

Sorbitol, Hydrated Silica, Water, Hydroxyapatite, Potassium Nitrate, Glycerin, Cellulose Gum, Sodium Cocoyl Glutamate, Sodium Methyl Cocoyl Taurate, Xylitol, Menthol, Stevioside, Mentha Pulegium Oil, Mentha Piperita Oil, Cooling Flavor, Mint Flavor, Sodium Chloride, Clove Mint Flaovr, Tocopheryl Acetate, Eugenia Caryophyllus (Clove) Flower Oil, Salvia Officinalis Leaf Extract, Aloe Barbadensis Leaf Extract, Rosmarinus Officinalis Leaf Extract, Calendula Officinalis Flower Extract

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Anti-cavity

Section 55106-9 (55106-9)

Active ingredient(s)

Sodium Fluoride 0.221%

Section 60561-8 (60561-8)

Other Information

■ Airtight container, Store in room temperature (1~30℃)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)