FDA.reportPublic FDA data

Alpha-Pro

Manufacturer
Dental Technologies, Inc.
Effective date
2025-11-04
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:04:05

Label at a glance#

ProductAlpha-Pro
Active ingredientSODIUM FLUORIDE, HYDROFLUORIC ACID
Label structure9 sections

Indications and uses

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.

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 m...

Label contents#

Full prescribing information#

Indications and Usage:

INDICATIONS & USAGE SECTION

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:

CONTRAINDICATIONS SECTION

Hypersensitivity to fluoride.

Warning:

WARNINGS SECTION

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:

PRECAUTIONS SECTION

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:

ADVERSE REACTIONS SECTION

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:

DOSAGE & ADMINISTRATION SECTION

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:

HOW SUPPLIED SECTION

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:

DESCRIPTION SECTION

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

PACKAGE LABEL.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_OrangeAPF_Orange

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1297381hydrofluoric acid 1 % / phosphoric acid 1.12 % / sodium fluoride 1.8 % Oral GelPSN3
1297381hydrofluoric acid 0.01 MG/MG / phosphoric acid 0.0112 MG/MG / sodium fluoride 0.018 MG/MG Oral GelSCD3
1297381hydrofluoric acid 1 % / phosphoric acid 1.12 % / sodium fluoride 1.8 % Oral GelSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128*+D7350094301002135098.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55346-0943-1Alpha-Pro497 g in 1 BOTTLEGEL4973

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HYDROFLUORIC ACIDACTIVE INGREDIENTRGL5YE86CZ1
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W71
Fluoride IonACTIVE MOIETYQ80VPU408O1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55346-094355346-0943-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
HYDROFLUORIC ACIDRGL5YE86CZACTIM

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22017-12-11full-release2026-05-31 20:25:01

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alpha-ProSODIUM FLUORIDE AND HYDROFLUORIC ACIDDental Technologies, Inc.a86ec65f-f6e1-474d-aeff-412a4716a92c2025-11-04Warnings, Adverse reactionsExact identifier
ndc (package): 55346-0943-1
ndc (product): 55346-0943
ndc11 (package): 55346094301
spl id: 42c899b3-99ed-0863-e063-6394a90ad112
spl set id: a86ec65f-f6e1-474d-aeff-412a4716a92c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.