SPL v1
SPL
SPL Set ID bbfbcf95-0fa2-578b-e053-2995a90a521a
Route
DENTAL
Published
Effective Date 2013-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Silicon Dioxide (20 g) .alpha.-tocopherol (0.1 g)
Inactive Ingredients
Xylitol Water Levomenthol Centella Asiatica

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2021-02-01
Description

Dental Type Silica, Tocopheryl Acetate

Medication Information

Warnings and Precautions

1) Be careful not to swallow, and rinse mouth thoroughly after use

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

3) If you are a child under 6 years of age, use a small amount of toothpaste as small as pea per use, and use under the supervision of a guardian to avoid sucking or swallowing

4 If a child under 6 years of age swallowed large quantities, consult a physician or dentist immediately

5) Keep out of the reach of children under 6 years

Indications and Usage

Brush the teeth with an appropriate amount of toothpaste.

Dosage and Administration

For dental use only

Description

Dental Type Silica, Tocopheryl Acetate

Section 50565-1

Keep out of reach of children

Section 51727-6

L-menthol, Other Salts, Rosmarinus Oficinalis (Rosemary) Extract, Centella asiatica extract, Potassium Acesulfame, Aloe barbadensis leaf extract, Glycerin, Sodium Chloride, Xylitol, Purified Water, Calendula officinalis extract, Cellulose gum, Chamomilla recutita (Matricaria) leaf extract, Sodium cocoyl glutamate, Sodium bicarbonate, Flavor, Charcoal Powder, Hydoxyapatite, Sodium hyaluronate

Section 51945-4

Section 55105-1

Helps protect against cavities

Section 55106-9

Dental Type Silica, Tocopheryl Acetate

Structured Label Content

Indications and Usage (34067-9)

Brush the teeth with an appropriate amount of toothpaste.

Dosage and Administration (34068-7)

For dental use only

Warnings and Precautions (34071-1)

1) Be careful not to swallow, and rinse mouth thoroughly after use

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

3) If you are a child under 6 years of age, use a small amount of toothpaste as small as pea per use, and use under the supervision of a guardian to avoid sucking or swallowing

4 If a child under 6 years of age swallowed large quantities, consult a physician or dentist immediately

5) Keep out of the reach of children under 6 years

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

L-menthol, Other Salts, Rosmarinus Oficinalis (Rosemary) Extract, Centella asiatica extract, Potassium Acesulfame, Aloe barbadensis leaf extract, Glycerin, Sodium Chloride, Xylitol, Purified Water, Calendula officinalis extract, Cellulose gum, Chamomilla recutita (Matricaria) leaf extract, Sodium cocoyl glutamate, Sodium bicarbonate, Flavor, Charcoal Powder, Hydoxyapatite, Sodium hyaluronate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Helps protect against cavities

Section 55106-9 (55106-9)

Dental Type Silica, Tocopheryl Acetate

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:25.641524 · Updated: 2026-03-14T22:59:22.971184