SPL v1
SPL
SPL Set ID 41197bb6-f6f4-c86d-e063-6294a90ad476
Route
ORAL
Published
Effective Date 2025-10-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Silicon Dioxide (18 g) Fluoride Ion (0.76 g)
Inactive Ingredients
Sorbitol Water Glycerin Sodium Cocoyl Glutamate

Identifiers & Packaging

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

Description

Active ingredient(s) Silica 18.0% Sodium Monofluorophosphate 0.76%


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)

• Fluoride content: 1,000 ppm

• Removes plaque (anti-plaque)

• Helps reduce bad breath by controlling oral bacteria

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 18.0% Sodium Monofluorophosphate 0.76%

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, Herb Mint Flavor, Menthol, Stevioside, Sodium Methyl Cocoyl Taurate, Mint Flavor, Sodium Bicarbonate, Titanium Dioxide, Xylitol, Propolis Wax, Chamomilla Recutita Flower Extract, Salvia Officinalis Leaf Extract, Camellia Sinensis 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

Section 55106-9

Active ingredient(s)

Silica 18.0%

Sodium Monofluorophosphate 0.76%

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)

• Fluoride content: 1,000 ppm

• Removes plaque (anti-plaque)

• Helps reduce bad breath by controlling oral bacteria

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, Herb Mint Flavor, Menthol, Stevioside, Sodium Methyl Cocoyl Taurate, Mint Flavor, Sodium Bicarbonate, Titanium Dioxide, Xylitol, Propolis Wax, Chamomilla Recutita Flower Extract, Salvia Officinalis Leaf Extract, Camellia Sinensis 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

Section 55106-9 (55106-9)

Active ingredient(s)

Silica 18.0%

Sodium Monofluorophosphate 0.76%

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)