Alpha-Pro
Sodium Fluoride and Hydrofluoric Acid · Gel · Dental
Uses
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 a 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.
Contraindications
Contraindications: Hypersensitivity to fluoride.
Warnings
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 Red No. 40.
Precautions
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 Fluoirde) 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-5097 Rev002
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.
Label text from the FDA structured product label by Dental Technologies, Inc. (revised Nov 4, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Sodium Fluoride in 2 products
- Hydrofluoric Acid in 2 products
Alpha-Pro NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 55346-0942 | Sodium Fluoride 7.9 mg/g; Hydrofluoric Acid 4.4 mg/g Gel | Dental Technologies, Inc. | UNAPPROVED DRUG OTHER |
| 55346-0943 | Sodium Fluoride 7.9 mg/g; Hydrofluoric Acid 4.4 mg/g Gel | Dental Technologies, Inc. | UNAPPROVED DRUG OTHER |
Frequently asked questions
What is Alpha-Pro 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 a year.
What are the side effects of Alpha-Pro?
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. See the full label for the complete list.
Who makes Alpha-Pro?
Alpha-Pro is listed by 1 labeler in the FDA NDC directory, including Dental Technologies, Inc..