98aebbec-aec0-1478-e053-2a95a90a03ea
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active Ingredient: Sodium Monofluorophosphate 0.16%, Sodium Fluoride 0.10%
Medication Information
Warnings and Precautions
Warnings:
Ask a doctor before use if you have:
Bleeding or redness lasting more than 2 weeks.
Pain, swelling, pus, loose teeth, or more spacing between teeth.
These may be signs of periodontitis, a serious form of gum disease.
Indications and Usage
Uses:
Aids in the prevention of dental cavities.
Dosage and Administration
Directions:
1) Adults and children 2 years of age and older: Brush teeth throughly preferably after each meal or at least twice a day or as directed by a dentist or doctor. 2) Children under 6 years: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. 3) Children under 2 years: Consult a dentist or doctor.
Description
Active Ingredient: Sodium Monofluorophosphate 0.16%, Sodium Fluoride 0.10%
Section 50565-1
Keep out of 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 51727-6
Inactive Ingredients: SORBITOL, HYDRATED SILICA, WATER, SILICA, SODIUM LAURYL SULFATE, TETRASODIUM PYROPHOSPHATE, PEG-32, CELLULOSE GUM, CITRUS FLAVOR, CITRUS AURANTIUM DULCIS(ORANGE) PEEL OIL, MINT FLAVOR, SODIUM SACCHARIN, XYLITOL, CAMELLIA SINENSIS EXTRACT, MENTHOL, PROPOLIS EXTRACT
Section 53413-1
Questions?
1-253-946-2344
Section 55105-1
Purpose: Anticaries
Section 55106-9
Active Ingredient: Sodium Monofluorophosphate 0.16%, Sodium Fluoride 0.10%
Package Label.principal Display Panel
Structured Label Content
Indications and Usage (34067-9)
Uses:
Aids in the prevention of dental cavities.
Dosage and Administration (34068-7)
Directions:
1) Adults and children 2 years of age and older: Brush teeth throughly preferably after each meal or at least twice a day or as directed by a dentist or doctor. 2) Children under 6 years: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. 3) Children under 2 years: Consult a dentist or doctor.
Warnings and Precautions (34071-1)
Warnings:
Ask a doctor before use if you have:
Bleeding or redness lasting more than 2 weeks.
Pain, swelling, pus, loose teeth, or more spacing between teeth.
These may be signs of periodontitis, a serious form of gum disease.
Section 50565-1 (50565-1)
Keep out of 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 51727-6 (51727-6)
Inactive Ingredients: SORBITOL, HYDRATED SILICA, WATER, SILICA, SODIUM LAURYL SULFATE, TETRASODIUM PYROPHOSPHATE, PEG-32, CELLULOSE GUM, CITRUS FLAVOR, CITRUS AURANTIUM DULCIS(ORANGE) PEEL OIL, MINT FLAVOR, SODIUM SACCHARIN, XYLITOL, CAMELLIA SINENSIS EXTRACT, MENTHOL, PROPOLIS EXTRACT
Section 53413-1 (53413-1)
Questions?
1-253-946-2344
Section 55105-1 (55105-1)
Purpose: Anticaries
Section 55106-9 (55106-9)
Active Ingredient: Sodium Monofluorophosphate 0.16%, Sodium Fluoride 0.10%
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)
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Source: dailymed · Ingested: 2026-02-15T12:02:45.164702 · Updated: 2026-03-14T23:02:27.804765