Label: ZOOBY GATOR GUM- sodium fluoride aerosol, foam
- NDC Code(s): 0273-0370-44
- Packager: Young Dental Manufacturing Co 1, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Updated September 26, 2011
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Product Name- ZOOBY, 1.23 % APF Foam (Gator Gum Flavor)
Distributed By - Denticator Earth City, MO 63045.
Net Weight - 4.4 OZ (125g)
R X 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.
For the topical application of fluoride to aid in the protection against dental caries. Optimized low pH for a 1 minute fluoride treatments. Close
- 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.
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 1-800-535-5053Close
- Product Label
Product Label of 1.23 % APF Foam (ZOOBY- Gator Gum)
- INGREDIENTS AND APPEARANCE
ZOOBY GATOR GUM
sodium fluoride aerosol, foam
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0273-0370 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) 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 Marketing Start Date Marketing End Date 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)