080e7f9d-273e-4f3b-bc84-f7c0dd3cf94c
34391-3
HUMAN PRESCRIPTION DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Fluoride Ion 1.23% ....................................Fluoride Treatment Gel 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 use.
Purpose
Fluoride Ion 1.23% ....................................Fluoride Treatment Gel Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.
Dosage and Administration
Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment twice a year. 1. After thorough prophylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth. 2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness). 3. 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 use.
Purpose
Fluoride Ion 1.23% ....................................Fluoride Treatment Gel Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.
Dosage and Administration
Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment twice a year. 1. After thorough prophylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth. 2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness). 3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.
Description
Fluoride Ion 1.23% ....................................Fluoride Treatment Gel Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.
Section 51945-4
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.
Inactive Ingredients:
Citric Acid, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol. May contain blue #1, green #3, red#3, red #40, yellow #5 (tartrazine), yellow #6 as a color additive.
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 use.
Dosage and Administration:
Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment twice a year.
1. After thorough prophylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.
2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).
3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.
Active Ingredient: Purpose:
Fluoride Ion 1.23% ....................................Fluoride Treatment Gel
Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.
Structured Label Content
Section 51945-4 (51945-4)
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.
Inactive Ingredients: (Inactive ingredients:)
Citric Acid, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol. May contain blue #1, green #3, red#3, red #40, yellow #5 (tartrazine), yellow #6 as a color additive.
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 use.
Dosage and Administration: (Dosage and administration:)
Shake well before use. This is a one minute or four minute fluoride gel for in-office patient use. It is normally used as a preventative caries treatment twice a year.
1. After thorough prophylaxis, fill two single or one dual tray, one third full with gel. Air dry teeth and insert trays into the mouth.
2. Instruct patient to bite down lightly but firmly for one minute (80% effectiveness) or four minutes (100% effectiveness).
3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.
Active Ingredient: Purpose: (Active ingredient: Purpose:)
Fluoride Ion 1.23% ....................................Fluoride Treatment Gel
Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.
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Source: dailymed · Ingested: 2026-02-15T11:36:30.706372 · Updated: 2026-03-14T21:46:33.832881