Topex® Fluoride Foams are indicated for topical application to teeth to aid in the prevention of dental caries.

The non-acidic nature of Neutral pH (NaF) is recommended for patients with ceramic or composite restorations.

1. Remove cap from can. If this is the first time using can, break the protective shipping tab by gently lifting up the trigger.

2. Shake can thoroughly for at least 10 seconds before each use.

3. Completely invert can and slowly depress trigger to dispense foam into a fluoride tray

4. Air dry teeth thoroughly and insert tray into patient’s mouth. Have patient close into the tray and use a slight chewing motion to ensure interproximal coverage.

5. Leave tray in contact with teeth between 1-4 minutes. Use a saliva ejector during treatment to minimize ingestion of product

6. Remove tray after elapsed time and have patient expectorate. Instruct patient to refrain from drinking, eating, or rinsing for 30 minutes after treatment.

Treatment frequency should not exceed 4 treatments per year.

APF topical Foam contains 2.73% sodium fluoride (1.23% fluoride ion).

NaF topical gel contains 2.0% sodium fluoride (0.9% fluoride ion).

Hypersensitivity to fluoride. Do not use if patient has a known allergy to fluoride or any of the other ingredients in this

product.

Do not swallow. Harmful if swallowed.

Keep out of reach of children.

This product is not intended for home or unsupervised consumer use.

Contents under pressure. Do not puncture or incinerate canister.

Safety and effectiveness below age 3 have not been established. There have been no long-term animal studies with this product to evaluate carcinogenic, mutagenic, or impairment of fertility potential.

Laboratory studies have indicated that repeated use of APF may dull porcelain, composite restorations and sealants.

Developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticarial, gastric distress, headache, and weakness.

If treatment dose is swallowed (less than 100 mg F ion), administer milk, limewater, or calcium-type antacid. In case of larger doses, use ipecac syrup emetic and immediately seek medical help.Overdose symptoms include nausea, vomiting, diarrhea, and abdominal pain.

Topex® Fluoride Foams are a family of topical fluoride foam products for professional application in trays. The family consists of APF Foam (1.23% fluoride ion at a pH between 3.0-4.5) and Neutral pH Foam (0.9% fluoride ion at a pH between 6.5 -7.5). Topex® Foam Fluoride products do not contain chlorofluorocarbon propellants.

Store at 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F) [See USP Controlled room temperature.]

Manufactured for:

Sultan Healthcare

1301 Smile Way • York, PA 17404 • USA

T oll Free: 800-637-8582 • Phone: 201-871-1232

Fax: 201-871-0321 • www.sultanhealthcare.com

Made in USA