SPL v2
SPL
SPL Set ID 67fac30f-f27a-a186-e053-2a91aa0a69d7
Route
DENTAL
Published
Effective Date 2013-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.5 g)
Inactive Ingredients
Silicon Dioxide Pyridoxine Hydrochloride

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-03-01
Description

SODIUM MONOFLUOROPHOSPHATE, SILICA, PYRIDOXINE HCI, ALCLOXA

Medication Information

Warnings and Precautions

Cautions:

1) If following symptoms occur after product use, stop using immediately: red spots, swelling, itchiness, and other skin irritations. 2) Avoid contact with eyes and open wounds. 3) Keep out of reach of children. 4) Do not store at high/low temperature. 5) Avoid direct sunlight.

■ If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

How to use:

1) Squeeze toothpaste on to toothbrush.

2) Brush thoroughly at least twice a day.

3) Brush for 3+ minutes.

4) Rinse out thoroughly with water.

Directions

■ Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

■ Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

■ Supervise children as necessary until capable of using without supervision.

■ Children under 2 years of age: Consult a dentist or doctor.

Dosage and Administration

For dental use only

Description

SODIUM MONOFLUOROPHOSPHATE, SILICA, PYRIDOXINE HCI, ALCLOXA

Section 50565-1

Keep out of reach of children

Section 51727-6

SILVER, HYDRATED SILICA, CELLULOSE GUM, SORBITIOL, GLYCERIN, PEG-32, XYLITOL, MENTHOL, WATER, ETC.

Section 51945-4

Section 55105-1

Aids in the prevention of dental cavities.

Section 55106-9

SODIUM MONOFLUOROPHOSPHATE, SILICA, PYRIDOXINE HCI, ALCLOXA

Structured Label Content

Indications and Usage (34067-9)

How to use:

1) Squeeze toothpaste on to toothbrush.

2) Brush thoroughly at least twice a day.

3) Brush for 3+ minutes.

4) Rinse out thoroughly with water.

Directions

■ Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

■ Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing).

■ Supervise children as necessary until capable of using without supervision.

■ Children under 2 years of age: Consult a dentist or doctor.

Dosage and Administration (34068-7)

For dental use only

Warnings and Precautions (34071-1)

Cautions:

1) If following symptoms occur after product use, stop using immediately: red spots, swelling, itchiness, and other skin irritations. 2) Avoid contact with eyes and open wounds. 3) Keep out of reach of children. 4) Do not store at high/low temperature. 5) Avoid direct sunlight.

■ 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)

SILVER, HYDRATED SILICA, CELLULOSE GUM, SORBITIOL, GLYCERIN, PEG-32, XYLITOL, MENTHOL, WATER, ETC.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Aids in the prevention of dental cavities.

Section 55106-9 (55106-9)

SODIUM MONOFLUOROPHOSPHATE, SILICA, PYRIDOXINE HCI, ALCLOXA

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:32.334950 · Updated: 2026-03-14T22:55:04.352870