PERFECT CHOICE- sodium fluoride and hydrofluoric acid gel 
Young Dental Manufacturing Co 1, LLC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

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. 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 Red #40

Reorder NO. APF 205PS

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

12000235A Rev 12/2006

Principal Display Panel

NDC 0273-7006-16

ZOOBY perfectchoice®

One

Minuteā„¢

APF Topical Gel

60 Second Treatment

Acidulated Phosphate Fluoride

1.23% Fluroide Ion

Rx only

Peppermint
Stick

Net Weight: 17.5 oz. (497g)

image of carton

PERFECT CHOICE 
sodium fluoride and hydrofluoric acid gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0273-7006
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion 7.9 mg  in 1 g
HYDROFLUORIC ACID (UNII: RGL5YE86CZ) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 4.4 mg  in 1 g
Product Characteristics
Color      Score     
Shape Size
Flavor PEPPERMINT (Peppermint Stick) Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0273-7006-16 497 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/31/2006
Labeler - Young Dental Manufacturing Co 1, LLC. (006309355)
Registrant - Young Dental Manufacturing Co 1, LLC. (006309355)
Establishment
Name Address ID/FEI Business Operations
Medical Products Laboratories, Inc. 002290302 manufacture(0273-7006)

Revised: 9/2015
Document Id: 7c7e76a9-80ab-41ed-b631-72a6938803aa
Set id: 3adcc1ba-6f5f-4700-b3c9-0467496f16ac
Version: 8
Effective Time: 20150930
 
Young Dental Manufacturing Co 1, LLC.