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
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Drug Label Information
Updated January 3, 2023
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- Official Label (Printer Friendly)
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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
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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
- Product label
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INGREDIENTS AND APPEARANCE
ZOOBY GATOR GUM
sodium fluoride aerosol, foamProduct 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; Type 0: Not a Combination Product 08/01/2010 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)