Zooby

Dosage Form: aerosol, foam

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)

Zooby  GATOR GUM sodium fluoride  aerosol, foam

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 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

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor BUBBLE GUM Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0273-0370-44 125 g In 1 CAN None

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: 09/2011Young Dental Manufacturing Co 1, LLC

More Zooby resources

• Zooby Use in Pregnancy & Breastfeeding
• Zooby Support Group
• 3 Reviews for Zooby - Add your own review/rating

Compare Zooby with other medications

• Prevention of Dental Caries