SPL v3
SPL
SPL Set ID 90a5f14b-97e8-7757-e053-2a95a90a3d97
Route
DENTAL
Published
Effective Date 2019-08-20
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 Fd&c Yellow No. 6 Fd&c Yellow No. 5 Fd&c Red No. 3 Fd&c Green No. 3 Fd&c Blue No. 1 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2019-08-01
Description

Fluoride Ion 1.23% 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 Use Only. This product is not intended for home or unsupervised use.

Purpose

Fluoride Treatment Gel

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.

Medication Information

Indications and Usage

A stable thixotropic fluoride treatment gel used to help prevent dental decay. For Professional Use Only. This product is not intended for home or unsupervised use.

Purpose

Fluoride Treatment Gel

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% 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.
Active Ingredient:

Fluoride Ion 1.23%

Available from 2.09% Sodium Fluoride and Hydrofluoric Acid

Other Information:

Do not store 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 (tartazine). Yellow #6 as a color additive.

Indications and Usage:
  • A stable thixotropic fluoride treatment gel used to help prevent dental decay.
  • For Professional 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 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:

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.
Active Ingredient:

Fluoride Ion 1.23%

Available from 2.09% Sodium Fluoride and Hydrofluoric Acid

Other Information:

Do not store 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 (tartazine). Yellow #6 as a color additive.

Indications and Usage:
  • A stable thixotropic fluoride treatment gel used to help prevent dental decay.
  • For Professional 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 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: 2026-02-15T11:36:36.162469 · Updated: 2026-03-14T21:47:00.329153