ZOOBY CHOCOLATE CHOW- sodium fluoride aerosol, foam 
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.

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Description

Product Name- ZOOBY, 1.23 % APF Foam (Chocolate Chow Flavor)

Distributed By - Denticator Earth City, MO  63045.

Net Weight - 4.4 OZ (125mg)

RX Only


ZOOBY, 1.23 % APF Foam (Chocolate Chow  Flavor) contains 1.23 % Fluoride Ion from 2.72 % Sodium Fluoride. Does not contain chlorofluorocarbon propellant. Gluten free.

Indications

For the topical application of fluoride to aid in the protection against dental caries. Optimized low pH for a 1 minute fluoride treatments.

Dosage and Administration


1. Break protective tab adjacent to trigger.

2. Shake can thoroughly for at least 15 seconds before each use.

3. Hold can completely upside down to dispense and fill fluoride tray by slowly depressing the nozzle. (The foam will expand slightly higher than the fluoride tray.)

4. Dry tooth surfaces prior to inserting tray(s) in mouth.

5. Insert tray(s) into patient’s mouth and have them bite down for 1-4 minutes.

6. Remove tray(s) and have patient expectorate.

7. Advise the patient not to eat, drink or rinse for 30 minutes after the treatment.


Warnings

Do not spray toward open flame. Contents under pressure. Do not puncture or incinerate. Keep out of reach of children. Store between 59-86º F (15-30º C). Keep from freezing.

Refer to Material Safety Data Sheet for additional information. For emergencies contact INFOTRAC at 1-800-535-5053

Product Label

Product  Label of 1.23 % APF Foam (Chocolate Chow)


product label chocolate chow

ZOOBY  CHOCOLATE CHOW
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0273-0392
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion ) Fluoride Ion 2.72 g  in 100 g
Product Characteristics
Color    Score    
ShapeSize
FlavorCHOCOLATEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0273-0392-44125 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/01/2010
Labeler - Young Dental Manufacturing Co 1, LLC (006309355)

Revised: 9/2011
Document Id: 569947be-56fb-4aab-8ed3-25dabfb81e20
Set id: 670fb658-56c5-4a9b-87bf-bb754a88a7cf
Version: 2
Effective Time: 20110926
 
Young Dental Manufacturing Co 1, LLC