SPL v5
SPL
SPL Set ID 5fa57e34-5827-4d37-a5dc-965750e5be50
Route
DENTAL
Published
Effective Date 2017-12-19
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 Titanium Dioxide Water Xanthan Gum Xylitol Fd&c Red No. 40

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2012-12-14
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 Red #40, 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 Red #40, 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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:36:37.677903 · Updated: 2026-03-14T21:47:00.329153