Zooby Aerosol, Foam
FDA Label NDC 0273-0394

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Young Dental Manufacturing Co 1, Llc for the product Zooby (NDC 0273-0394). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description, indications, dosage and administration, warnings, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Description

Product Name- ZOOBY, 1.23 % APF Foam (Turtle Melon Flavor)

Distributed By - Denticator Earth City, MO  63045.

Net Weight - 4.4 OZ (125g)

RX Only


ZOOBY, 1.23 % APF Foam (Turtle Melon 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 (Turtle Melon)

Product Label Turtle Melon (Turtle Melon)

Product Label Turtle Melon (Turtle Melon)



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