Drugplain

Alpha-Pro 4.4 mg/g

Sodium Fluoride and Hydrofluoric Acid · GEL · Dental Technologies, Inc.

No Recall HistoryCurrently in Shortage
Plain English

Alpha-Pro is a prescription gel containing sodium fluoride and hydrofluoric acid at 4.4 mg/g, taken dental. Manufactured by Dental Technologies, Inc..

Key Facts

Brand Name
Alpha-Pro
Generic Name
Sodium Fluoride and Hydrofluoric Acid
NDC Code (Product)
55346-0942
Manufacturer
Dental Technologies, Inc.
Strength
4.4 mg/g
Dosage Form
GEL
Route
DENTAL
Marketing Status
HUMAN PRESCRIPTION DRUG
Marketing Start
04/01/2013

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 & 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.

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 Yellow No.6.

Contraindications

Contraindications: Hypersensitivity to fluoride.

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.

Frequently Asked Questions

What is Alpha-Pro used for?

Alpha-Pro contains Sodium Fluoride and Hydrofluoric Acid. It is a gel taken dental. Consult your doctor for specific uses.

Is Alpha-Pro a controlled substance?

Alpha-Pro is not classified as a controlled substance by the DEA.

What is the generic name for Alpha-Pro?

The generic name for Alpha-Pro is Sodium Fluoride and Hydrofluoric Acid. There are no other listed brand versions of Sodium Fluoride and Hydrofluoric Acid.

What is the NDC code for Alpha-Pro 4.4 mg/g?

The NDC (National Drug Code) for Alpha-Pro 4.4 mg/g is 55346-0942, listed by Dental Technologies, Inc..

Product NDC

55346-0942

Package NDC

55346-0942-1

Other Alpha-Pro Dosages

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)