PERFECT CHOICE- sodium fluoride and hydrofluoric acid gel

Perfect Choice by

Drug Labeling and Warnings

Perfect Choice by is a Prescription medication manufactured, distributed, or labeled by Young Dental Manufacturing Co 1, LLC., Medical Products Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS AND USAGE:

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

Warnings:

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:

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:

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:

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:

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:

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

NDC: 0273-7004-16

ZOOBY®

PERFECT CHOICE®

1.23% APF TOPICAL GEL

TICKLED PINK

STRAWBERRY

60-Second

Treatment Acidulated

Phosphate Fluoride

1.23% Fluoride Ion

Net Weight: 17.5 oz. (497g)

INGREDIENTS AND APPEARANCE

PERFECT CHOICE 
sodium fluoride and hydrofluoric acid gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0273-7004
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	7.9 g  in 1 g
HYDROFLUORIC ACID (UNII: RGL5YE86CZ) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	4.4 mg  in 1 g

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY (Tickled Pink Strawberry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0273-7004-16	497 g in 1 BOTTLE; Type 0: Not a Combination Product	12/22/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/22/2018

Labeler - Young Dental Manufacturing Co 1, LLC. (006309355)

Registrant - Young Dental Manufacturing Co 1, LLC. (006309355)

Establishment
Name	Address	ID/FEI	Business Operations
Medical Products Laboratories, Inc		002290302	manufacture(0273-7004)