ALPHA-PRO- sodium fluoride and hydrofluoric acid gel 
Dental Technologies, Inc.

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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DTI APF - Strawberry

Indications and Usage:

Topical application of APF gel is indicated in the prevention of dental caries. This treatment is normally used two times per year and should not exceed four times a year.

Contraindications:

Hypersensitivity to fluoride.

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. Contains FD&C Red No. 40.

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. The following adverse reactions are possible in individuals hypersensitive to fluoride: eczema, atopic dermatitis, urticaria, gastric distress, headache, and weakness.

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 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 Fluoirde) in 0.1 Molar Phosphoric Acid.

DENTAL TECHNOLOGIES

LINCOLNWOOD, ILLINOIS 60712 USA

www.dentaltech.com

Questions or Comments?

Call: 1-800-835-0885 (US) or 1-847-677-5500

PM-5097 Rev002

Principal Display Panel

DENTAL TECHNOLOGIES

www.dentaltech.com

ALPHA-PRO® APF

TOPICAL GEL

60 SECOND TREATMENT

Acidulated Phosphate Fluoride

1.23% Fluoride Ion

Rx Only

Strawberry

REF No. 009-4201-002

NET WEIGHT: 17.5 oz. (497g)

APF_Strawberry

ALPHA-PRO 
sodium fluoride and hydrofluoric acid gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55346-0942
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
FlavorSTRAWBERRY (Strawberry) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55346-0942-1497 g in 1 BOTTLE; Type 0: Not a Combination Product04/01/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/01/2013
Labeler - Dental Technologies, Inc. (148312838)

Revised: 12/2017
Document Id: 60132265-446f-7e66-e053-2991aa0a8237
Set id: efe3646d-9eb1-4a49-aeb4-c4c224056851
Version: 2
Effective Time: 20171211
 
Dental Technologies, Inc.