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Zooby growlin grrrape - Medication Information

Product NDC Code 0273-0358
Drug Name

Zooby growlin grrrape

Type Brand
Active Ingredients
Sodium fluoride 2.72 g/100g
Route DENTAL
Dosage Form AEROSOL, FOAM
RxCUI drug identifier 248389,
1193240
Labeler Name Young Dental Manufacturing Co 1, LLC
Packages
Package NDC Code Description
0273-0358-44 125 g in 1 can (0273-0358-44)
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Description

General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.
Description Product Name- ZOOBY, 1.23 % APF Foam (Growlin Grrrape Flavor) Distributed By - Denticator Earth City, MO 63045. Net Weight - 4.4 OZ (125g) RX Only ZOOBY, 1.23 % APF Foam (Growlin Grrrape Flavor) contains 1.23 % Fluoride Ion from 2.72 % Sodium Fluoride. The Product is free from Does not contain chlorofluorocarbon propellant. Gluten free.

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
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.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Indications For the topical application of fluoride to aid in the protection against dental caries. Optimized low pH for a 1 minute fluoride treatments.

Spl product data elements

Usually a list of ingredients in a drug product.
ZOOBY Growlin Grrrape Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Product Label Product Label of 1.23 % APF Foam (Growlin Grrrape) product label growlin grrrape

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API