ZOOBY
c257d280-8cf3-43e4-b7b7-0a46f493d5b6
HUMAN PRESCRIPTION DRUG LABEL
Jan 3, 2023
Young Dental Manufacturing Co 1, LLC
DUNS: 006309355
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sodium Fluoride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (1)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Product label
INDICATIONS & USAGE SECTION
Indications
For the topical application of fluoride to aid in the protection against dental caries. Optimized low pH for a 1 minute fluoride treatments.
WARNINGS AND PRECAUTIONS SECTION
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
DESCRIPTION SECTION
Description
Product Name- ZOOBY, 1.23 % APF Foam (Gator Gum Flavor)
Distributed By - Denticator Earth City, MO 63045.
Net Weight - 4.4 OZ (125g)
RX Only
ZOOBY, 1.23 % APF Foam (Gator Gum Flavor) contains 1.23 % Fluoride Ion from 2.72 % Sodium Fluoride.Does not contain chlorofluorocarbon propellant. Gluten free.
DOSAGE & ADMINISTRATION SECTION
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.