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Perfect Choice Fluoride Gel Prescribing Information

Package insert / product label
Generic name: sodium fluoride and hydrofluoric acid
Dosage form: dental gel
Drug class: Mouth and throat products

Medically reviewed by Drugs.com. Last updated on Aug 24, 2023.

Indications and Usage for Perfect Choice Fluoride Gel

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/Side Effects

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.

Perfect Choice Fluoride Gel 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 is Perfect Choice Fluoride Gel 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 0273-7006-16

ZOOBY®

PERFECT CHOICE®

1.23% APF TOPICAL GEL

STRIPED

PEPPERMINT
STICK

60-Second

Treatment Acidulated

Phosphate Fluoride

1.23% Fluoride Ion

Net Weight: 17.5 oz. (497g)

apf_peppermint

PERFECT CHOICE
sodium fluoride and hydrofluoric acid gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0273-7006
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION7.9 mg in 1 g
HYDROFLUORIC ACID (UNII: RGL5YE86CZ) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION4.4 mg in 1 g
Product Characteristics
Color Score
ShapeSize
FlavorPEPPERMINT (Peppermint Stick) Imprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0273-7006-16497 g in 1 BOTTLE; Type 0: Not a Combination Product12/22/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/22/2018
Labeler - Young Dental Manufacturing Co 1, LLC. (006309355)
Registrant - Medical Products Laboratories, Inc (002290302)
Establishment
NameAddressID/FEIBusiness Operations
Medical Products Laboratories, Inc002290302manufacture(0273-7006)