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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

Contains: FD&C Yellow #6

Reorder NO. APF 209VO

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

12000255A Rev 12/2006

Principal Display Panel

NDC 0273-7003-16

perfectchoice®

One

Minute™

APF Topical Gel

60 Second Treatment

Acidulated Phosphate Fluoride

1.23% Fluoride Ion

Rx only




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:0273-7003
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:0273-7003-16 497 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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Be sure to consult your doctor before taking any medication!
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