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Alpha-Pro Gel Prescribing Information

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

Medically reviewed by Drugs.com. Last updated on Mar 25, 2024.

Indications and Usage for Alpha-Pro Gel

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 per year.

Contraindications

Hypersensitivity to fluoride.

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. Contains FD&C Yellow No.6.

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

Alpha-Pro 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 Alpha-Pro Gel 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.

Alpha-Pro Gel Description

1.23% w/w Fluoride Ion (0.79% from Sodium Fluoride and 0.44% from Hydrogen Fluoride) 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-5098 Rev002

Principal Display Panel

DENTAL TECHNOLOGIES

www.dentaltech.com

ALPHA-PRO® APF

TOPICAL GEL

60 SECOND TREATMENT

Acidulated Phosphate Fluoirde

1.23% Fluoride Ion

Rx Only

Vanilla Orange

REF No. 009-4301-002

NET WEIGHT: 17.5 oz. (497g)

APF_Orange

ALPHA-PRO
sodium fluoride and hydrofluoric acid gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55346-0943
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
FlavorORANGE (Vanilla Orange) Imprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55346-0943-1497 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)