PERFECT CHOICE- sodium fluoride and hydrofluoric acid gel 
Young Dental Manufacturing Co 1, LLC.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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APF - Peppermint Stick

INDICATIONS AND USAGE:

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

Warning:

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 0273-7006-16

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)

Revised: 12/2018
Document Id: 3125bde3-0397-40fb-87e7-e83e21823b1a
Set id: 3adcc1ba-6f5f-4700-b3c9-0467496f16ac
Version: 12
Effective Time: 20181214
 
Young Dental Manufacturing Co 1, LLC.