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  5. Label Information: Zooby Happy Hippo Cake

FDA Label for Zooby Happy Hippo Cake

View Indications, Usage & Precautions

Table of Contents

    1. DESCRIPTION
    2. INDICATIONS
    3. DOSAGE AND ADMINISTRATION
    4. WARNINGS
    5. PRODUCT LABEL

Zooby Happy Hippo Cake Product Label

The following document was submitted to the FDA by the labeler of this product Young Dental Manufacturing Co 1, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 59-86° F (15-30° 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 - happy hippo

product label zooby happy hippo cake - happy hippo



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