b3cec2cd-6a67-68ca-e053-2995a90ad738

SPL v1
SPL
SPL Set ID b3cec2cd-6a67-68ca-e053-2995a90ad738
Route
dental
Published
Effective Date 2013-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (0.4 g)
Inactive Ingredients
xylitol water aminocaproic acid silicon dioxide

Identifiers & Packaging

Marketing Status
otc monograph final active Since 2020-11-01
Description

Sodium Monofluorophosphate

Medication Information

Warnings and Precautions

Keep out of reach of children under 6 years old.

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

Active Ingredient

Sodium Monofluorophosphate

Indications and Usage

Apply an appropriate amount to your toothbrush and brush your teeth by brushing

Dosage and Administration

For dental use only

Description

Sodium Monofluorophosphate

Section 50565-1

Keep out of reach of children

Section 51727-6

Precipitated Calcium Carbonate, Dibasic Calcium Phosphate, Aminocaproic Acid, Aluminium Chlorohydroxy Allantoinate, D-Sorbitol Solution, Concentrated Glycerin, Polyethylene Glycol 1500, Xanthangum, Sodium Cocoyl Glutamate, Silicon Dioxide, Titanium Oxide, Enzymatically Modified Stevia, Xylitol, Sodium Chloride, Ascorbic Acid, Mentha Oil, l-Menthol, Spearmint Oil, Water

Section 51945-4

Section 55105-1

For dental care

Structured Label Content

Warnings and Precautions (34071-1)

Keep out of reach of children under 6 years old.

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

Active Ingredient (55106-9)

Sodium Monofluorophosphate

Indications and Usage (34067-9)

Apply an appropriate amount to your toothbrush and brush your teeth by brushing

Dosage and Administration (34068-7)

For dental use only

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51727-6 (51727-6)

Precipitated Calcium Carbonate, Dibasic Calcium Phosphate, Aminocaproic Acid, Aluminium Chlorohydroxy Allantoinate, D-Sorbitol Solution, Concentrated Glycerin, Polyethylene Glycol 1500, Xanthangum, Sodium Cocoyl Glutamate, Silicon Dioxide, Titanium Oxide, Enzymatically Modified Stevia, Xylitol, Sodium Chloride, Ascorbic Acid, Mentha Oil, l-Menthol, Spearmint Oil, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

For dental care

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:01.389094 · Updated: 2026-03-14T22:58:51.217894