One Minute Sodium Fluoride Gel

Generic Name: sodium fluoride, phosphoric acid and hydrofluoric acidsodium fluoride, phosphoric acid and hydrofluoric acid
Dosage Form: dental gel

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.

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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: FDandC Red #40 and FDandC Blue #1


Reorder NO. APF 204JG

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

12000335 Rev 12/2006

Principal Display Panel

NDC 0273-7001-16

perfectchoice®

One

Minute™

APF Topical Gel

60 Second Treatment

Acidulated Phosphate Fluoride

1.23% Fluroide Ion

Rx only


Juicy
Grape

Net Weight: 17.5 oz. (497g)


ONE MINUTE  SODIUM FLUORIDE
apf topical gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0273-7001
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (Fluoride Ion) Sodium Fluoride 18 mg  in 1 g
Phosphoric Acid (Phosphoric Acid) Phosphoric Acid 11.2 mg  in 1 g
Hydrofluoric Acid (Hydrofluoric Acid) Hydrofluoric Acid 10 mg  in 1 g
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE (Juicy Grape) Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:0273-7001-16 497 g in 1 BOTTLE
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)
Revised: 05/2012
 
Young Dental Manufacturing Co 1, LLC.



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