SPL v1
SPL
SPL Set ID ce35c6f3-21da-1890-e053-2995a90aa62e
Route
DENTAL
Published
Effective Date 2021-09-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Silicon Dioxide (14 g) Pyrophosphoric Acid (0.5 g) Fluoride Ion (0.36 g)
Inactive Ingredients
Xylitol Water Sodium Chloride

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2021-09-20

Description

Silicon Dioxide (Dental Type Silica), Sodium Pyrophosphate (Tetrasodium Pyrophosphate), Sodium Monofluorophosphate


Medication Information

Warnings and Precautions

Storage method

1. Keep it at room temperature in a classified container.

2. Cover and store at room temperature.

3. Store in a not moisture and cool place.

4. Air may come out during use of this product, but there is no problem with its weight.

Usage Precautions

1. Be careful not to swallow. Rinse mouth thoroughly after use

2. If the use of toothpaste causes abnormalities such as gums or mouth injury, discontinue use and consult a doctor or dentist.

3. For children under 6 years of age, use a small amount of toothpaste as small as pea per use, and use under the guidance of a guardian to avoid sucking or swallowing.

4. If a child under 6 years old swallows large amount, consult with a doctor or dentist immediately.

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

Indications and Usage

Put an appropriate amount on a toothbrush and brush teeth.

Dosage and Administration

For dental use only

Description

Silicon Dioxide (Dental Type Silica), Sodium Pyrophosphate (Tetrasodium Pyrophosphate), Sodium Monofluorophosphate

Section 50565-1

Keep out of reach of children

Section 51727-6

D-Sorbitol Solution, Concentrated Glycerin, Xanthangum, Sodium Cocoyl Glutamate, Ascorbic Acid, Hydroxyapatite, Xylitol, Sodium Chloride, Green Tea Extract, Eucalyptus Extract, Matricaria Extract, Aloe Extract, Sage Extract, Grapefruit Seed Extract, natural raspberry flavor, Water

Section 51945-4

Section 55105-1

ANTI-CAVITY

Section 55106-9

Silicon Dioxide (Dental Type Silica), Sodium Pyrophosphate (Tetrasodium Pyrophosphate), Sodium Monofluorophosphate


Structured Label Content

Indications and Usage (34067-9)

Put an appropriate amount on a toothbrush and brush teeth.

Dosage and Administration (34068-7)

For dental use only

Warnings and Precautions (34071-1)

Storage method

1. Keep it at room temperature in a classified container.

2. Cover and store at room temperature.

3. Store in a not moisture and cool place.

4. Air may come out during use of this product, but there is no problem with its weight.

Usage Precautions

1. Be careful not to swallow. Rinse mouth thoroughly after use

2. If the use of toothpaste causes abnormalities such as gums or mouth injury, discontinue use and consult a doctor or dentist.

3. For children under 6 years of age, use a small amount of toothpaste as small as pea per use, and use under the guidance of a guardian to avoid sucking or swallowing.

4. If a child under 6 years old swallows large amount, consult with a doctor or dentist immediately.

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

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

D-Sorbitol Solution, Concentrated Glycerin, Xanthangum, Sodium Cocoyl Glutamate, Ascorbic Acid, Hydroxyapatite, Xylitol, Sodium Chloride, Green Tea Extract, Eucalyptus Extract, Matricaria Extract, Aloe Extract, Sage Extract, Grapefruit Seed Extract, natural raspberry flavor, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

ANTI-CAVITY

Section 55106-9 (55106-9)

Silicon Dioxide (Dental Type Silica), Sodium Pyrophosphate (Tetrasodium Pyrophosphate), Sodium Monofluorophosphate


Advanced Ingredient Data


Raw Label Data

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