Your browser does not support JavaScript! PERFECT CHOICE (SODIUM FLUORIDE AND HYDROFLUORIC ACID) GEL [YOUNG DENTAL MANUFACTURING CO 1, LLC.]
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PERFECT CHOICE (sodium fluoride and hydrofluoric acid) gel
[Young Dental Manufacturing Co 1, LLC.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

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

perfectchoice®

One

Minute™

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 TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0273-7006
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Fluoride Ion7.9 mg  in 1 g
HYDROFLUORIC ACID (FLUORIDE ION) FLUORIDE ION4.4 mg  in 1 g
Product Characteristics
Color    Score    
ShapeSize
FlavorPEPPERMINT (Peppermint Stick) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0273-7006-16497 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/31/2006
Labeler - Young Dental Manufacturing Co 1, LLC. (006309355)

Revised: 11/2012
 
Young Dental Manufacturing Co 1, LLC.

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