FDA.reportPublic FDA data

APF Gel - Vanilla Orange

Manufacturer
Young Dental Manufacturing Co 1, LLC. | Medical Products Laboratories, Inc
Effective date
2018-12-22
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-05-31 20:27:11

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 on patients with an allergy to fluoride.

Precautions:

PRECAUTIONS SECTION

For professional use only. This product is not intened 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 Yellow #6

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0273-7003-16

ZOOBY®

PERFECT CHOICE®

1.23% APF TOPICAL GEL

ROARIN'

VANILLA

ORANGE

60-Second

Treatment Acidulated

Phosphate Fluoride

1.23% Fluoride Ion

Net Weight: 17.5 oz. (497g)

vanilla_orangevanilla_orange

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1297381hydrofluoric acid 1 % / phosphoric acid 1.12 % / sodium fluoride 1.8 % Oral GelPSN10
1297387perfectchoice One Minute 1.23 % Oral GelPSN10
1297387hydrofluoric acid 0.01 MG/MG / phosphoric acid 0.0112 MG/MG / sodium fluoride 0.018 MG/MG Oral Gel [Perfect Choice One Minute]SBD10
1297381hydrofluoric acid 0.01 MG/MG / phosphoric acid 0.0112 MG/MG / sodium fluoride 0.018 MG/MG Oral GelSCD10
1297381hydrofluoric acid 1 % / phosphoric acid 1.12 % / sodium fluoride 1.8 % Oral GelSY10
1297387Perfect Choice One Minute (hydrofluoric acid 1 % / phosphoric acid 1.12 % / sodium fluoride 1.8 % ) Oral GelSY10

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0273-7003-162020-01-31C16284748780-19d75b9d0-487c-f424-e053-dadaa90a57ceAPF Gel - Vanilla Orange

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0273-7003-16Perfect Choice497 g in 1 BOTTLEGEL49710

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0273-7003PERFECT CHOICE (SODIUM FLUORIDE AND HYDROFLUORIC ACID) GEL [YOUNG DENTAL MANUFACTURING CO 1, LLC.]10Legacy NDC, 1 package rows20181224_3b2d5edc-ddc2-4c91-aeba-9ba982c7793e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HYDROFLUORIC ACIDACTIVE INGREDIENTRGL5YE86CZ7
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W77
FLUORIDE IONACTIVE MOIETYQ80VPU408O7

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
0273-70030273-7003-16

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
d1ea1d9c-1a6d-4d21-8383-e1ca03e270793b2d5edc-ddc2-4c91-aeba-9ba982c7793e2018-12-22Warnings, Adverse reactionsExact identifier
spl id: d1ea1d9c-1a6d-4d21-8383-e1ca03e27079
spl set id: 3b2d5edc-ddc2-4c91-aeba-9ba982c7793e

Reported adverse events (FAERS/openFDA)#

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