ZOOBY Happy Hippo Cake

ZOOBY HAPPY HIPPO CAKE- 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 (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)

product label zooby happy hippo cake
(click image for full-size original)

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 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 VANILLA Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0273-0393-44 125 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)
Establishment
Name Address ID/FEI Operations
Medical Products Laboratories, Inc 002290302 manufacture (0273-0393)

Revised: 12/2018 Young Dental Manufacturing Co 1, LLC

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