SPL v6
SPL
SPL Set ID d01543c1-a8dd-2833-e053-2995a90aab9c
Route
DENTAL
Published
Effective Date 2022-02-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Silicon Dioxide (15 g) Pyrophosphoric Acid (0.5 g) Fluoride Ion (0.758 g)
Inactive Ingredients
Xylitol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2022-02-26

Description

Sodium Monofluorophosphate, Dental type silica, Tetrasodium Pyrophosphate


Medication Information

Warnings and 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

Sodium Monofluorophosphate, Dental type silica, Tetrasodium Pyrophosphate

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

Enzymatically Modified Stevia

Sodium Chloride

Flavor(Apple mint)

Spearmint Oil

Grapefruit Seed Extract

Green Tea Extract

Matricaria Extract

Sage Extract

Eucalyptus Extract

Water

Section 51945-4

Section 55105-1

Reduces bad breath, Prevents tartar buildup, Keeps mouth clean, Makes teeth white and strong, Prevent periodontal disease, gum disease

Section 55106-9

Sodium Monofluorophosphate, Dental type silica,

Tetrasodium Pyrophosphate


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)

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

Enzymatically Modified Stevia

Sodium Chloride

Flavor(Apple mint)

Spearmint Oil

Grapefruit Seed Extract

Green Tea Extract

Matricaria Extract

Sage Extract

Eucalyptus Extract

Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Reduces bad breath, Prevents tartar buildup, Keeps mouth clean, Makes teeth white and strong, Prevent periodontal disease, gum disease

Section 55106-9 (55106-9)

Sodium Monofluorophosphate, Dental type silica,

Tetrasodium Pyrophosphate


Advanced Ingredient Data


Raw Label Data

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