SPL v1
SPL
SPL Set ID 3488b090-c30d-e6d2-e063-6294a90a3569
Route
ORAL
Published
Effective Date 2025-05-07
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 Sodium Cocoyl Glutamate Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-04-01

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 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

Sorbitol, Water, Glycerin, Sodium Cocoyl Glutamate, PEG-32, Cellulose Gum, Citrus Mint Flavor, Menthol, Stevioside, Sodium Bicarbonate, Mentha Piperita Oil, Lemon Flavor, Sodium Methyl Cocoyl Taurate, Titanium Dioxide, Xylitol, Propolis Wax, Chamomilla Recutita Flower Extract, Salvia Officinalis Leaf Extract, Camellia Sinensis Leaf Extract, Eucalyptus Globulus Leaf Extract, Citrus Paradisi Fruit Extract, Centella Asiatica Extract

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 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

Sorbitol, Water, Glycerin, Sodium Cocoyl Glutamate, PEG-32, Cellulose Gum, Citrus Mint Flavor, Menthol, Stevioside, Sodium Bicarbonate, Mentha Piperita Oil, Lemon Flavor, Sodium Methyl Cocoyl Taurate, Titanium Dioxide, Xylitol, Propolis Wax, Chamomilla Recutita Flower Extract, Salvia Officinalis Leaf Extract, Camellia Sinensis Leaf Extract, Eucalyptus Globulus Leaf Extract, Citrus Paradisi Fruit Extract, Centella Asiatica Extract

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)