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Alpha-Pro
sodium fluoride and hydrofluoric acid · Alpha-Pro is a prescription drug containing sodium fluoride and hydrofluoric acid, made by Dental Technologies, Inc..
- Type
- Prescription
- Drug class
- Not classified
- Route
- Dental
- Manufacturers
- 1
Topical application of APF gel is indicated in the prevention of dental caries.
Related recalls
FDA drug recalls that name this drug or its active ingredient
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Uses
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
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.
Contraindications
Hypersensitivity to fluoride.
Warnings
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.
Precautions
For professional use only. This product is not intended for home or unsupervised consumer use. Repeated use may cause dulling of porcelain and ceramic restorations.
Side effects (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.
Description
Active Ingredients: 1.23% w/w Fluoride Ion (0.79% from Sodium Fluoride and 0.44% from Hydrogen Fluoride) in
0.1Molar 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
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.
Forms and strengths
From the FDA NDC Directory · 2 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Gel | 7.9 mg/g / 4.4 mg/g | dental | 2 |
Manufacturers and labels
2 FDA labels
- Dental Technologies, Inc.Shown hereLabel 11/04/2025 · NDC 55346-0943Full label
- Dental Technologies, Inc.Label 11/04/2025 · NDC 55346-0942Full label
Alpha-Pro: common questions
- What is Alpha-Pro used for?
- Topical application of APF gel is indicated in the prevention of dental caries.
- What are the side effects of Alpha-Pro?
- Developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. See the full side effects section on this page, and ask your doctor or pharmacist about any side effect that bothers you.
- Is Alpha-Pro a prescription drug?
- Yes. Alpha-Pro is a prescription (Rx) drug.
- Who makes Alpha-Pro?
- Dental Technologies, Inc. lists Alpha-Pro with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 11/04/2025 · Label text is shown as published by the manufacturer. Not medical advice