SPL v1
SPL
SPL Set ID 487cd5b9-28f3-392d-e063-6394a90a9ba1
Route
ORAL
Published
Effective Date 2026-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
.alpha.-tocopherol (0.2 g) Pyrophosphoric Acid (0.5 g) Silicon Dioxide (17 g) Fluoride Ion (0.22 g)
Inactive Ingredients
Sorbitol Water Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2026-01-02

Description

Active ingredient(s) Silica 17.0% Sodium Fluoride 0.22% Tocopheryl Acetate 0.20% Tetrasodium Pyrophosphate 0.50%


Medication Information

Warnings and Precautions

Warnings

• Keep out of reach of children under 6 years of age.

• If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

Use(s)

• Helps remove plaque and tartar buildup

• Helps prevent cavities

• Helps reduce gum inflammation and promote healthy teeth

Dosage and Administration

Directions

• Adults and children 2 years of age and older : Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician

• Children 2 to 6 years : Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

• Children under 2 years : Ask a dentist or physician

Description

Active ingredient(s) Silica 17.0% Sodium Fluoride 0.22% Tocopheryl Acetate 0.20% Tetrasodium Pyrophosphate 0.50%

Section 50565-1

Keep out of reach of children under 6 years of age.

Section 51727-6

Inactive ingredients

D-Sorbitol Solution, Water(Aqua), Silicon Dioxide, Concentrated Glycerin, Sodium Cocoyl Glutamate, Polyethylene Glycol 1500, Carboxymethylcellulose Sodium, Sodium Fluoride, Tocopherol Acetate, Sodium Pyrophosphate, Sodium Bicarbonate, Titanium Oxide, Xylitol, Enzymatically Modified Stevia, Propolis Extract, Aloe Extract, Matricaria Extract, Eucalyptus Extract, Sage Extract, Green Tea Extract, Rosemary Extract, Calendula Extract, Centella Extract, Lemon Extract, Leontopodium Alpinum Extract, Lactic Acid Bacteria Fermented Solution, Grapefruit Seed Extract, L-Menthol, Lemon Oil, Herb Mint Flavor, Herb

Section 51945-4

Section 53413-1

Questions

+82-1588-9709

Section 55105-1

Purpose

Antiplaque, Anticavity, Antigingivitis, Antitartar

Section 55106-9

Active ingredient(s)

Silica 17.0%

Sodium Fluoride 0.22%

Tocopheryl Acetate 0.20%

Tetrasodium Pyrophosphate 0.50%

Section 60561-8

Other Information

• Store at temperatures between 1°C and 30°C

• Use within 36 months from the date of manufacture

• Do not store in high/low temperatures or direct sunlight


Structured Label Content

Indications and Usage (34067-9)

Use(s)

• Helps remove plaque and tartar buildup

• Helps prevent cavities

• Helps reduce gum inflammation and promote healthy teeth

Dosage and Administration (34068-7)

Directions

• Adults and children 2 years of age and older : Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician

• Children 2 to 6 years : Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

• Children under 2 years : Ask a dentist or physician

Warnings and Precautions (34071-1)

Warnings

• Keep out of reach of children under 6 years of age.

• If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

Keep out of reach of children under 6 years of age.

Section 51727-6 (51727-6)

Inactive ingredients

D-Sorbitol Solution, Water(Aqua), Silicon Dioxide, Concentrated Glycerin, Sodium Cocoyl Glutamate, Polyethylene Glycol 1500, Carboxymethylcellulose Sodium, Sodium Fluoride, Tocopherol Acetate, Sodium Pyrophosphate, Sodium Bicarbonate, Titanium Oxide, Xylitol, Enzymatically Modified Stevia, Propolis Extract, Aloe Extract, Matricaria Extract, Eucalyptus Extract, Sage Extract, Green Tea Extract, Rosemary Extract, Calendula Extract, Centella Extract, Lemon Extract, Leontopodium Alpinum Extract, Lactic Acid Bacteria Fermented Solution, Grapefruit Seed Extract, L-Menthol, Lemon Oil, Herb Mint Flavor, Herb

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions

+82-1588-9709

Section 55105-1 (55105-1)

Purpose

Antiplaque, Anticavity, Antigingivitis, Antitartar

Section 55106-9 (55106-9)

Active ingredient(s)

Silica 17.0%

Sodium Fluoride 0.22%

Tocopheryl Acetate 0.20%

Tetrasodium Pyrophosphate 0.50%

Section 60561-8 (60561-8)

Other Information

• Store at temperatures between 1°C and 30°C

• Use within 36 months from the date of manufacture

• Do not store in high/low temperatures or direct sunlight


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)