Your browser does not support JavaScript! ZOOBY GATOR GUM (SODIUM FLUORIDE) AEROSOL, FOAM [YOUNG DENTAL MANUFACTURING CO 1, LLC]
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ZOOBY GATOR GUM (sodium fluoride) aerosol, foam
[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

Description

Product Name- ZOOBY, 1.23 % APF Foam (Gator Gum Flavor)

Distributed By - Denticator Earth City, MO  63045.

Net Weight - 4.4 OZ (125g)

RX Only


ZOOBY, 1.23 % APF Foam (Gator Gum 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 (ZOOBY- Gator Gum)

product label gator gum



ZOOBY  GATOR GUM
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0273-0370
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
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0273-0370-44125 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
 
Young Dental Manufacturing Co 1, LLC

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