Zooby

Generic Name: sodium fluoride
Dosage Form: aerosol, foam

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.

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


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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)




Zooby  GATOR GUM
sodium fluoride aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0273-0370
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Sodium Fluoride (Fluoride Ion ) Fluoride Ion 2.72 g  in 100 g
Product Characteristics
Color      Score     
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:0273-0370-44 125 g in 1 CAN
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/01/2010
Labeler - Young Dental Manufacturing Co 1, LLC (006309355)
Revised: 09/2011
 
Young Dental Manufacturing Co 1, LLC



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