SPL v3
SPL
SPL Set ID 96900a7d-32bc-2612-e053-2995a90a602a
Route
DENTAL
Published
Effective Date 2013-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Silicon Dioxide (2 g) Fluoride Ion (0.35 g)
Inactive Ingredients
Xylitol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2019-10-01
Description

Silica, Sodium Monofluorosphate

Medication Information

Warnings and Precautions

Keep out of the 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

Brush your teeth with a suitable amount of brush

Dosage and Administration

For dental use only

Description

Silica, Sodium Monofluorosphate

Section 50565-1

Keep out of reach of children

Section 51727-6

Sorbitol, Water, Glycerin, Stevioside, Hydrated Silica, etc.

Section 51945-4

Section 55105-1

For dental care

Section 55106-9

Silica, Sodium Monofluorosphate

Structured Label Content

Indications and Usage (34067-9)

Brush your teeth with a suitable amount of brush

Dosage and Administration (34068-7)

For dental use only

Warnings and Precautions (34071-1)

Keep out of the 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

Section 51727-6 (51727-6)

Sorbitol, Water, Glycerin, Stevioside, Hydrated Silica, etc.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

For dental care

Section 55106-9 (55106-9)

Silica, Sodium Monofluorosphate

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:56.474463 · Updated: 2026-03-14T22:55:45.140912