FDA.reportPublic FDA data

APF Gel - Grape

Manufacturer
Young Dental Manufacturing Co 1, LLC.
Effective date
2018-12-14
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-05-31 20:27:10

Label at a glance#

ProductPerfect Choice
Active ingredientSODIUM FLUORIDE, HYDROFLUORIC ACID
Label structure8 sections

Indications and uses

Topical application of APF gel is indicated in the prevention of dental caries.

Dosage and administration

After thorough prophylaxis, place gel in applicator tray (not more than 1/3 full). Throughly air-dry teeth and insert tray(s) in mouth. Gel may also be swab applied. Instruct patient to bite down slightly but firmly for one to four minutes. A slight chewing motion enhances coverage interproximally. Remove tray(s) and have patient expectorate excess gel. Instruct patient not to eat, drink or rinse for at least 30 m...

Label contents#

Full prescribing information#

INDICATIONS AND USAGE:

INDICATIONS & USAGE SECTION

Topical application of APF gel is indicated in the prevention of dental caries.

Warning:

WARNINGS SECTION

Keep out of reach of children. Do not swallow.

If swallowed during treatment, administer milk, limewater, or antacid. If larger dose is ingested (more than 1/4 ounce), contact poison control and immediately seek medical help. Do not use in patients with an allergy to fluoride.

Precautions:

PRECAUTIONS SECTION

For professional use only. This product is not intended for home or unsupervised consumer use. Repeated use may cause dulling of porcelain and ceramic restorations.

Adverse reactions:

ADVERSE REACTIONS SECTION

Developing teeth of children under age 6 may become permanently discolored if excessive amounts are repeatedly swallowed. Individuals hypersensitive to fluoride may have an adverse reaction.

DOSAGE AND ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

After thorough prophylaxis, place gel in applicator tray (not more than 1/3 full). Throughly air-dry teeth and insert tray(s) in mouth. Gel may also be swab applied. Instruct patient to bite down slightly but firmly for one to four minutes. A slight chewing motion enhances coverage interproximally. Remove tray(s) and have patient expectorate excess gel. Instruct patient not to eat, drink or rinse for at least 30 minutes.

HOW SUPPLIED:

HOW SUPPLIED SECTION

A thixotropic gel, one bottle contains up to 68 individual applications. Store at controlled room temperature 20°- 25°C (68°-77°F).

Do not allow to freeze.

ACTIVE INGREDIENTS:

DESCRIPTION SECTION

1.23% w/w Fluoride Ion (0.79% from Sodium Fluoride and 0.44% from Hydrogen Fluoride) in 0.1 Molar Phosphoric Acid.

Contains: FD&C Red #40 and FD&C Blue #1

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0273-7001-16

ZOOBY®

PERFECT CHOICE®

1.23% APF TOPICAL GEL

GROWLIN'

GRRRAPE®

60-Second

Treatment Acidulated

Phosphate Fluoride

1.23% Fluroide Ion

Net Weight: 17.5 oz. (497g)

GROWLIN_GRAPEGROWLIN_GRAPE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1297381hydrofluoric acid 1 % / phosphoric acid 1.12 % / sodium fluoride 1.8 % Oral GelPSN11
1297387perfectchoice One Minute 1.23 % Oral GelPSN11
1297387hydrofluoric acid 0.01 MG/MG / phosphoric acid 0.0112 MG/MG / sodium fluoride 0.018 MG/MG Oral Gel [Perfect Choice One Minute]SBD11
1297381hydrofluoric acid 0.01 MG/MG / phosphoric acid 0.0112 MG/MG / sodium fluoride 0.018 MG/MG Oral GelSCD11
1297381hydrofluoric acid 1 % / phosphoric acid 1.12 % / sodium fluoride 1.8 % Oral GelSY11
1297387Perfect Choice One Minute (hydrofluoric acid 1 % / phosphoric acid 1.12 % / sodium fluoride 1.8 % ) Oral GelSY11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0273-7001-162020-01-31C16284748780-19d75b9d1-1bab-f424-e053-dadaa90a57ceAPF Gel - Grape

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0273-7001-16Perfect Choice497 g in 1 BOTTLEGEL49711

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0273-7001PERFECT CHOICE (SODIUM FLUORIDE AND HYDROFLUORIC ACID) GEL [YOUNG DENTAL MANUFACTURING CO 1, LLC.]11Legacy NDC, 1 package rows20181222_88fa8d66-86d3-40c2-a6f7-b29ec2f060e8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HYDROFLUORIC ACIDACTIVE INGREDIENTRGL5YE86CZ8
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W78
FLUORIDE IONACTIVE MOIETYQ80VPU408O8

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0273-70010273-7001-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
HYDROFLUORIC ACIDRGL5YE86CZACTIM

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
307c4797-e3c6-46c1-b950-36014bd3d92788fa8d66-86d3-40c2-a6f7-b29ec2f060e82018-12-14Warnings, Adverse reactionsExact identifier
spl id: 307c4797-e3c6-46c1-b950-36014bd3d927
spl set id: 88fa8d66-86d3-40c2-a6f7-b29ec2f060e8

Reported adverse events (FAERS/openFDA)#

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