Alpha-Pro description, usages, side effects, indications, overdosage, supplying and lots more!

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Alpha-Pro

Dental Technologies, Inc.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Indications and Usage:

Topical application of APF gel is indicated in the prevention of dental caries.

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.

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. Individuals hypersensitive to fluoride may have an adverse reaction.

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.

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

www.dentaltech.com

Questions or Comments?

Call: 1-800-835-0885 (US) or 1-847-677-5500

PM-5098 Rev000

Principal Display Panel

DENTAL TECHNOLOGIES

www.dentaltech.com

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)
Alpha-Pro

Alpha-Pro

Sodium Fluoride and Hydrofluoric Acid GEL

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:55346-0943
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE FLUORIDE ION 7.9 mg
Hydrofluoric Acid Hydrofluoric Acid 4.4 mg

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55346-0943-1 497 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2013-04-01


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