FDA Label for Alpha-pro
View Indications, Usage & Precautions
Alpha-pro Product Label
The following document was submitted to the FDA by the labeler of this product Dental Technologies, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
Contraindications:
Hypersensitivity to fluoride.
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.
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.
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.
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.
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.
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
Questions or Comments?
Call: 1-800-835-0885 (US) or 1-847-677-5500
PM-5098 Rev002
Principal Display Panel
DENTAL TECHNOLOGIES
ALPHA-PRO® APF
TOPICAL GEL
60 SECOND TREATMENT
Acidulated Phosphate Fluoirde
1.23% Fluoride Ion
Rx Only
Vanilla Orange
REF No. 009-4301-002
NET WEIGHT: 17.5 oz. (497g)
* Please review the disclaimer below.