SPL v1
SPL
SPL Set ID 4115d122-3090-d3e5-e063-6294a90aafb6
Route
ORAL
Published
Effective Date 2025-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
.alpha.-tocopherol (0.2 g) Silicon Dioxide (15 g) Fluoride Ion (0.22 g)
Inactive Ingredients
Sodium Cocoyl Glutamate Sorbitol Water 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%


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 protect against cavities

• Helps reduce gum inflammation and maintain healthy gums

• Aids in the prevention of periodontal disease

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%

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, Menthol, Mentha Piperita Oil, Sodium Lauroyl Sarcosinate, Stevioside, Sodium Bicarbonate, Cooling Flavor, Aqua Mint Flavor, Xylitol, Propolis Wax, Hydrolyzed Collagen, Chamomilla Recutita Flower Extract, Salvia Officinalis Leaf Extract, Camellia Sinensis Leaf Extract, Citrus Paradisi Fruit Extract, Centella Asiatica Extract, Aloe Barbadensis Leaf Extract, Eucalyptus Globulus Leaf Extract, Calendula Officinalis Flower Extract, Rosmarinus Officinalis Leaf Extract

Section 51945-4

Section 53413-1

Questions

+82-1588-9709

Section 55105-1

Purpose

Antiplaque, Anticavity, Antigingivitis

Section 55106-9

Active ingredient(s)

Silica 17.0%

Sodium Fluoride 0.22%

Tocopheryl Acetate 0.20%

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 protect against cavities

• Helps reduce gum inflammation and maintain healthy gums

• Aids in the prevention of periodontal disease

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, Menthol, Mentha Piperita Oil, Sodium Lauroyl Sarcosinate, Stevioside, Sodium Bicarbonate, Cooling Flavor, Aqua Mint Flavor, Xylitol, Propolis Wax, Hydrolyzed Collagen, Chamomilla Recutita Flower Extract, Salvia Officinalis Leaf Extract, Camellia Sinensis Leaf Extract, Citrus Paradisi Fruit Extract, Centella Asiatica Extract, Aloe Barbadensis Leaf Extract, Eucalyptus Globulus Leaf Extract, Calendula Officinalis Flower Extract, Rosmarinus Officinalis Leaf Extract

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions

+82-1588-9709

Section 55105-1 (55105-1)

Purpose

Antiplaque, Anticavity, Antigingivitis

Section 55106-9 (55106-9)

Active ingredient(s)

Silica 17.0%

Sodium Fluoride 0.22%

Tocopheryl Acetate 0.20%

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

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