Sodium Fluoride And Hydrofluoric Acid
FDA Drug Information • Also known as: Alpha-Pro
- Brand Names
- Alpha-Pro
- Route
- DENTAL
- Dosage Form
- GEL
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
Active Ingredients: 1.23% w/w Fluoride Ion (0.79% from Sodium Fluoride and 0.44% from Hydrogen Fluoride) in 0.1 Molar Phosphoric Acid. DENTAL TECHNOLOGIES LINCOLNWOOD, ILLINOIS 60712 USA www.dentaltech.com Questions or Comments? Call: 1-800-835-0885 (US) or 1-847-677-5500 PM-5098 Rev002
What Is Sodium Fluoride And Hydrofluoric Acid Used For?
Indications and Usage: Topical application of APF gel is indicated in the prevention of dental caries. This treatment is normally used two times per year and should not exceed four times per year.
Dosage and Administration
Dosage and Administration: After thorough prophylaxis, place gel in applicator tray (not more than 1/3 full). Throughly air-dry teeth and insert tray(s) in mouth. Gel may also be swab applied. Instruct patient to bite down slightly but firmly for one to four minutes. A slight chewing motion enhances coverage interproximally. Remove tray(s) and have patient expectorate excess gel. Instruct patient not to eat, drink or rinse for at least 30 minutes.
Side Effects (Adverse Reactions)
Adverse Reactions: 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, urticaria, gastric distress, headache, and weakness.
Warnings and Precautions
Warning: Keep out of reach of children. Do not swallow. If swallowed during treatment, administer milk, limewater, or antacid. If larger dose is ingested (more than 1/4 ounce), contact poison control and immediately seek medical help. Contains FD&C Yellow No.6.
Contraindications
Contraindications: Hypersensitivity to fluoride.
How Supplied
How Supplied: A gel, one bottle contains up to 68 individual applications. Store at controlled room temperature 20°- 25°C (68°-77°F). Do not allow to freeze.
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.