e1dc8865-a193-44e7-b628-3c4e5d595318
e1dc8865-a193-44e7-b628-3c4e5d595318
34391-3
HUMAN PRESCRIPTION DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Indications and Usage
This is a prescription fluoride treatment gel used to help prevent dental decay.
Dosage and Administration
Shake lightly before use. This is a four minute topical fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year. 1. After thorough prophylaxsis, 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 four minutes. 3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.
Purpose
Anticaries Treatment.
Description
Sodium Fluoride 2% (0.9% Fluoride Ion)
Medication Information
Indications and Usage
This is a prescription fluoride treatment gel used to help prevent dental decay.
Purpose
Anticaries Treatment.
Dosage and Administration
Shake lightly before use. This is a four minute topical fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year. 1. After thorough prophylaxsis, 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 four minutes. 3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.
Description
Sodium Fluoride 2% (0.9% Fluoride Ion)
Section 51945-4
Purpose:
Anticaries Treatment.
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.
- This product contains a concentrated fluoride amount and is available by prescription only. It should be used under professional supervision.
Active Ingredient:
Sodium Fluoride 2% (0.9% Fluoride Ion)
Other Information:
- Do not store above 25°C/77°F.
- Do not freeze.
Inactive Ingredients:
Citric Acid, FD&C Green #3, FD&C Yellow #5 (tartrazine) as a color additive, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Potassium Hydroxide, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol.
Indications and Usage:
This is a prescription fluoride treatment gel used to help prevent dental decay.
Dosage and Administration:
Shake lightly before use. This is a four minute topical fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.
1. After thorough prophylaxsis, 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 four minutes.
3. 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:
Anticaries Treatment.
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.
- This product contains a concentrated fluoride amount and is available by prescription only. It should be used under professional supervision.
Active Ingredient:
Sodium Fluoride 2% (0.9% Fluoride Ion)
Other Information:
- Do not store above 25°C/77°F.
- Do not freeze.
Inactive Ingredients:
Citric Acid, FD&C Green #3, FD&C Yellow #5 (tartrazine) as a color additive, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, Potassium Hydroxide, Sodium Benzoate, Sodium Saccharin, Titanium Dioxide, Water, Xanthan Gum, Xylitol.
Indications and Usage:
This is a prescription fluoride treatment gel used to help prevent dental decay.
Dosage and Administration:
Shake lightly before use. This is a four minute topical fluoride gel for in-office patient use. It is normally used as a preventative caries treatment two times a year.
1. After thorough prophylaxsis, 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 four minutes.
3. Remove trays. Instruct patient to expectorate any excess gel and not to eat or drink for at least 30 minutes.
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T11:36:31.098724 · Updated: 2026-03-14T21:46:33.832881