SPL v6
SPL
SPL Set ID 281fe774-91e1-403f-b58a-92bcc09292ab
Route
DENTAL
Published
Effective Date 2019-01-15
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (4.086 g)
Inactive Ingredients
Magnesium Aluminum Silicate Phosphoric Acid Polysorbate 20 Potassium Hydroxide Sodium Benzoate Saccharin Sodium Citric Acid Monohydrate Water Xanthan Gum Xylitol Fd&c Red No. 40 Titanium Dioxide Fd&c Blue No. 1 Fd&c Green No. 3 Fd&c Red No. 3 Fd&c Yellow No. 5 Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2013-03-01
Description

Sodium Fluoride 2%

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 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 four minutes. 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 consumer use.

Purpose

Fluoride Treatment Gel

Dosage and Administration

Shake well before use. This is a 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 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%

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 Conrol Center right away.
  • Read directions carefully before using.
Active Ingredient:

Sodium Fluoride 2%

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, Potassium Hydroxide, 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 consumer use.
Dosage and Administration:

Shake well before use. This is a 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 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:

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 Conrol Center right away.
  • Read directions carefully before using.
Active Ingredient:

Sodium Fluoride 2%

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, Potassium Hydroxide, 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 consumer use.
Dosage and Administration:

Shake well before use. This is a 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 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

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Source: dailymed · Ingested: 2026-02-15T11:40:51.476931 · Updated: 2026-03-14T22:04:26.530663