ZOOBY HAPPY HIPPO CAKE- sodium fluoride aerosol, foam

ZOOBY by

Drug Labeling and Warnings

ZOOBY by is a Prescription medication manufactured, distributed, or labeled by Young Dental Manufacturing Co 1, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Description

Product Name- ZOOBY, 1.23 % APF Foam (Happy Hippo Cake Flavor)

Distributed By - Denticator Earth City, MO 63045.

Net Weight - 4.4 OZ (125g)

RX Only

ZOOBY, 1.23 % APF Foam (Happy Hippo Cake 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- Happy Hippo Cake)

INGREDIENTS AND APPEARANCE

ZOOBY  HAPPY HIPPO CAKE
sodium fluoride aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0273-0393
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	VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0273-0393-44	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)

Establishment
Name	Address	ID/FEI	Business Operations
Medical Products Laboratories, Inc		002290302	manufacture(0273-0393)