Label at a glance#

ProductPerfect Choice

Active ingredientHYDROFLUORIC ACID, SODIUM FLUORIDE

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 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

Active Ingredients:

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.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0273-7002-16

ZOOBY

PERFECT CHOICE®

1.23% APF TOPICAL GEL

TURTLE

MELON

60-Second

Treatment Acidulated

Phosphate Fluoride

1.23% Fluroide Ion

Net Weight: 17.5 oz. (497g)

turtle_melon

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1297381	hydrofluoric acid 1 % / phosphoric acid 1.12 % / sodium fluoride 1.8 % Oral Gel	PSN	11
1297387	perfectchoice One Minute 1.23 % Oral Gel	PSN	11
1297387	hydrofluoric acid 0.01 MG/MG / phosphoric acid 0.0112 MG/MG / sodium fluoride 0.018 MG/MG Oral Gel [Perfect Choice One Minute]	SBD	11
1297381	hydrofluoric acid 0.01 MG/MG / phosphoric acid 0.0112 MG/MG / sodium fluoride 0.018 MG/MG Oral Gel	SCD	11
1297381	hydrofluoric acid 1 % / phosphoric acid 1.12 % / sodium fluoride 1.8 % Oral Gel	SY	11
1297387	Perfect Choice One Minute (hydrofluoric acid 1 % / phosphoric acid 1.12 % / sodium fluoride 1.8 % ) Oral Gel	SY	11

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Data code	Code 128	+H810NDC02737002161F		4630.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0273-7002-16	2020-01-31	C162847	48780-1	9d75b9d0-a11a-f424-e053-dadaa90a57ce	APF Gel - Watermelon

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0273-7002-16	Perfect Choice	497 g in 1 BOTTLE	GEL	497		11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0273-7002	PERFECT CHOICE (SODIUM FLUORIDE AND HYDROFLUORIC ACID) GEL [YOUNG DENTAL MANUFACTURING CO 1, LLC.]	11	Legacy NDC, 1 package rows	20181224_11d08dc0-fa26-4506-830c-d809f50c5411.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Hydrofluoric Acid	ACTIVE INGREDIENT	RGL5YE86CZ	8
Sodium Fluoride	ACTIVE INGREDIENT	8ZYQ1474W7	8
FLUORIDE ION	ACTIVE MOIETY	Q80VPU408O	8

Products#

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

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

Perfect Choice
Sodium Fluoride and Hydrofluoric Acid
HYDROFLUORIC ACID
FLUORIDE ION
SODIUM FLUORIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0273-7002	0273-7002-16

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
Name	UNII	Kind
HYDROFLUORIC ACID	RGL5YE86CZ	ACTIM
SODIUM FLUORIDE	8ZYQ1474W7	ACTIM

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
59a348e7-898e-4d36-a686-c982f096099d			11d08dc0-fa26-4506-830c-d809f50c5411	2018-12-24	Warnings, Adverse reactions	Exact identifier spl id: 59a348e7-898e-4d36-a686-c982f096099d spl set id: 11d08dc0-fa26-4506-830c-d809f50c5411

Reported adverse events (FAERS/openFDA)#

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

APF Gel - Watermelon