ZOOBY Growlin Grrrape

ZOOBY GROWLIN GRRRAPE- sodium fluoride aerosol, foam
Young Dental Manufacturing Co 1, LLC

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.

Product Name- ZOOBY, 1.23 % APF Foam (Growlin Grrrape Flavor)

Distributed By — Denticator Earth City, MO 63045.

Net Weight — 4.4 OZ (125g)

RX Only

ZOOBY, 1.23 % APF Foam (Growlin Grrrape Flavor) contains 1.23 % Fluoride Ion from 2.72 % Sodium Fluoride. The Product is free from 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 (Growlin Grrrape)

product label growlin grrrape
(click image for full-size original)
ZOOBY GROWLIN GRRRAPE
sodium fluoride aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0273-0358
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 GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0273-0358-44 125 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: 01/2023 Young Dental Manufacturing Co 1, LLC

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