ZOOBY

Manufacturer
Young Dental Manufacturing Co 1, LLC
Effective date
2023-01-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 20:45:58

Label at a glance#

ProductZOOBY Spearmint Safari
Active ingredientSODIUM FLUORIDE
Label structure5 sections

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....

Label contents#

Full prescribing information#

Description

DESCRIPTION SECTION

Product Name- ZOOBY, 1.23 % APF Foam (Spearmint Safari Flavor)

Distributed By - Denticator Earth City, MO 63045.

Net Weight - 4.4 OZ (125g)

RX Only

ZOOBY, 1.23 % APF Foam (Spearmint Safari Flavor) contains 1.23 % Fluoride Ion from 2.72 % Sodium Fluoride.Does not contain chlorofluorocarbon propellant. Gluten free.

Indications

INDICATIONS & USAGE SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS AND PRECAUTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product  Label of 1.23 % APF Foam (Spearmint Safari)

product label spearmint safariproduct label spearmint safari

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
248389sodium fluoride 2.72 % Oral FoamPSN5
1193240ZOOBY 2.72 % Oral FoamPSN5
1193240sodium fluoride 27.2 MG/ML Oral Foam [Zooby Fluoride Foam]SBD5
248389sodium fluoride 27.2 MG/ML Oral FoamSCD5
248389sodium fluoride 2.72 % (fluoride ion 1.23 % ) Oral FoamSY5
248389sodium fluoride 2.72 % Oral FoamSY5
1193240Zooby Fluoride Foam 27.2 MG/ML Oral FoamSY5
1193240Zooby Gator Gum 2.72 % (1.23 % fluoride ion) Oral FoamSY5
1193240Zooby Growlin' Grrrape 2.72 % (1.23 % fluoride ion) Oral FoamSY5
1193240Zooby Happy Hippo Cake 2.72 % (1.23 % fluoride ion) Oral FoamSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0273-0357-44ZOOBYSpearmint Safari125 g in 1 CANAEROSOL, FOAM1255

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0273-0357ZOOBY SPEARMINT SAFARI (SODIUM FLUORIDE) AEROSOL, FOAM [YOUNG DENTAL MANUFACTURING CO 1, LLC]5Current NDC, Legacy NDC, 1 package rows20230105_bd49f704-4fc4-42a3-aa87-2b41d15d86bb.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W72
Fluoride IonACTIVE MOIETYQ80VPU408O2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0273-03570273-0357-44

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZOOBY Spearmint SafariSODIUM FLUORIDEYoung Dental Manufacturing Co 1, LLCbd49f704-4fc4-42a3-aa87-2b41d15d86bb2023-01-03WarningsExact identifier
ndc (package): 0273-0357-44
ndc (product): 0273-0357
ndc11 (package): 00273035744
spl id: f1623deb-4a71-3e68-e053-2a95a90aec16
spl set id: bd49f704-4fc4-42a3-aa87-2b41d15d86bb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.