9cc82e34-9b2d-4815-b9ff-99d2292faff2

SPL v6
SPL
SPL Set ID 9cc82e34-9b2d-4815-b9ff-99d2292faff2
Route
dental
Published
Effective Date 2019-03-05
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (5.6 g)
Inactive Ingredients
citric acid monohydrate magnesium aluminum silicate phosphoric acid polysorbate 20 sodium benzoate saccharin sodium water xanthan gum xylitol fd&c red no. 40 titanium dioxide

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
unapproved drug other active Since 2012-12-14
Indications and Usage

This is a prescription fluoride treatment gel used to help prevent dental decay. • For Professional 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 or four minute 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 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.

Purpose

Anticaries Treatment.

Description

Fluoride Ion 1.23%. A stable thixotropic gel providing 1.23% fluoride ion. Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.

Medication Information

Indications and Usage

This is a prescription fluoride treatment gel used to help prevent dental decay. • For Professional Use Only. This product is not intended for home or unsupervised consumer use.

Purpose

Anticaries Treatment.

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 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 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%. A stable thixotropic gel providing 1.23% fluoride ion. Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.

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.
  • Read directions carefully before using.
Active Ingredient:

Fluoride Ion 1.23%. A stable thixotropic gel providing 1.23% fluoride ion. Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.

Other Information:

Do not store above 25°C/77°F.

Do not freeze.

Inactive Ingredients:

Citric Acid, FD&C Red #40, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, 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.

• For Professional 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 or four minute 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 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.

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.
  • Read directions carefully before using.
Active Ingredient:

Fluoride Ion 1.23%. A stable thixotropic gel providing 1.23% fluoride ion. Available from 2.09% Sodium Fluoride and Hydrofluoric Acid.

Other Information:

Do not store above 25°C/77°F.

Do not freeze.

Inactive Ingredients:

Citric Acid, FD&C Red #40, Flavor, Magnesium Aluminum Silicate, Phosphoric Acid, Polysorbate 20, 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.

• For Professional 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 or four minute 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 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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:36:35.580235 · Updated: 2026-03-14T21:46:51.765235