SPL v1
SPL
SPL Set ID dc82bc1f-c32b-72c2-e053-2995a90a1072
Route
DENTAL
Published
Effective Date 2021-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
.alpha.-tocopherol (0.2 g) Silicon Dioxide (17 g) Pyrophosphoric Acid (0.5 g) Fluoride Ion (0.76 g)
Inactive Ingredients
Xylitol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2021-11-06
Description

Silicon Dioxidel,Tetrasodium Pyrophosphate,Tocopherol Acetate,Sodium Monofluorophosphate

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

Silicon Dioxidel,Tetrasodium Pyrophosphate,Tocopherol Acetate,Sodium Monofluorophosphate

Section 50565-1

Keep out of reach of children

Section 51727-6

D-Sorbitol Solution,Concentrated Glycerin,Xanthan gum,Sodium Cocoyl Glutamate,Ascorbic Acid,Hydroxyapatite,Xylitol,Sodium

Chloride,Grapefruit Seed Extract,Glycyrrhiza Extract,Green Tea Extract,Matricaria Extract,Sage Extract,Aloe

Extract,Eucalyptus Extract,Ginseng Extract,Propolis Extract,Ginger Powder,Myrrh Tincture,l-Menthol,Flavor,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

Silicon Dioxidel,Tetrasodium Pyrophosphate,Tocopherol Acetate,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)

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,Xanthan gum,Sodium Cocoyl Glutamate,Ascorbic Acid,Hydroxyapatite,Xylitol,Sodium

Chloride,Grapefruit Seed Extract,Glycyrrhiza Extract,Green Tea Extract,Matricaria Extract,Sage Extract,Aloe

Extract,Eucalyptus Extract,Ginseng Extract,Propolis Extract,Ginger Powder,Myrrh Tincture,l-Menthol,Flavor,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)

Silicon Dioxidel,Tetrasodium Pyrophosphate,Tocopherol Acetate,Sodium Monofluorophosphate

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:00:11.408660 · Updated: 2026-03-14T23:00:33.718954