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Young Dental Manufacturing Co 1, LLC.


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.



Precautions:

For professional use only. 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.

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



Reorder NO. APF 203MM

TIME TO REORDER! CALL YOUR DENTAL DEALER.

DISTRIBUTED BY

BIOTROL

Earth City, MO 63045

www.biotrol.com

Questions or Comments?

Call: 1-800-822-8550

12000215A Rev 12/2006

Principal Display Panel

NDC 0273-7007-16

perfectchoice®

One

Minute™

APF Topical Gel

60 Second Treatment

Acidulated Phosphate Fluoride

1.23% Fluroide Ion

Rx only

Creamy

Marshmallow

Net Weight: 17.5 oz. (497g)

Perfect Choice


Perfect Choice

Sodium Fluoride and Hydrofluoric Acid GEL

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:0273-7007
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:0273-7007-16 497 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2006-08-31


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