6a0f889d-5f27-496f-b830-d778ee867ade
34391-3
HUMAN PRESCRIPTION DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
1.23% Fluoride Ion Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.
Indications and Usage
• A stable thixotropic fluoride treatment gel used to help prevent dental decay. • For Professional Office Use Only. This product is not intended for home or unsupervised consumer use.
Purpose
Fluoride Treatment Gel
Dosage and Administration
Shake well before use. This is a one minute of four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment twice a year. • After thorough prophylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth. • Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness). • Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.
Medication Information
Indications and Usage
• A stable thixotropic fluoride treatment gel used to help prevent dental decay. • For Professional Office Use Only. This product is not intended for home or unsupervised consumer use.
Purpose
Fluoride Treatment Gel
Dosage and Administration
Shake well before use. This is a one minute of four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment twice a year. • After thorough prophylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth. • Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness). • Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.
Description
1.23% Fluoride Ion Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.
Section 51945-4
Purpose:
Fluoride Treatment Gel
Warnings:
• Keep out of reach of children.
• Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away.
• Read directions carefully before using.
Other Information:
Do not store above 25°C/77°F. Do not freeze.
Active Ingredients:
1.23% Fluoride Ion
Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.
Inactive Ingredients:
Citric Acid, FD&C Blue #1, FD&C Red #3, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol
Indications and Usage:
• A stable thixotropic fluoride treatment gel used to help prevent dental decay.
• For Professional Office Use Only. This product is not intended for home or unsupervised consumer use.
Dosage and Administration:
Shake well before use. This is a one minute of four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment twice a year.
• After thorough prophylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.
• Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).
• Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.
Structured Label Content
Section 51945-4 (51945-4)
Purpose:
Fluoride Treatment Gel
Warnings:
• Keep out of reach of children.
• Do not swallow. If product is accidentally swallowed in quantities greater than would normally occur with a treatment gel, seek medical help or contact a Poison Control Center right away.
• Read directions carefully before using.
Other Information: (Other information:)
Do not store above 25°C/77°F. Do not freeze.
Active Ingredients:
1.23% Fluoride Ion
Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.
Inactive Ingredients:
Citric Acid, FD&C Blue #1, FD&C Red #3, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol
Indications and Usage: (Indications and usage:)
• A stable thixotropic fluoride treatment gel used to help prevent dental decay.
• For Professional Office Use Only. This product is not intended for home or unsupervised consumer use.
Dosage and Administration: (Dosage and administration:)
Shake well before use. This is a one minute of four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment twice a year.
• After thorough prophylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.
• Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).
• Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.
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Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:36:37.683306 · Updated: 2026-03-14T21:47:10.458721