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.
Alpha-pro Gel
FDA Label NDC 55346-0943
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dental Technologies, Inc. for the product Alpha-pro (NDC 55346-0943). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding indications and usage:, contraindications:, warning:, precautions:, adverse reactions:, dosage and administration:, how supplied:, active ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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)
Apf_orange (5098)
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