FDA.reportPublic FDA data

DentiCare Pro-Gel

Manufacturer
AMD Medicom Inc.
Effective date
2021-01-27
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:54:36

Label at a glance#

ProductDentiCare Pro-Gel Neutral Sodium Fluoride
Active ingredientSODIUM FLUORIDE
Label structure6 sections

Dosage and administration

A topical anti-caries preparation in a pH 7 thixotropic gel base In-Office Directions for use: Following prophylaxis treatment, fill 1/3 of tray with gel Insert tray in the patient's mouth Have patient bite down lightly for 4 minutes Remove tray(s) and have patient expectorate excess Advise patient not to eat, drink or rinse for 30 minutes after the application Home Care Directions for use: Use only on the advice ...

Label contents#

Full prescribing information#

General Information

DESCRIPTION SECTION

AMD Medicom Inc.

DentiCare Pro-Gel

1.1% Neutral Sodium Fluoride Gel for Topical Fluoride Applications (0.5% Fluoride Ions)

Unflavoured / Dye Free

16.23 fl oz / 480mL

NDC 64778-0220-1

NPN 80008841

RX Only in US

Item code 10022-UN

Indications and Directions

DOSAGE & ADMINISTRATION SECTION

A topical anti-caries preparation in a pH 7 thixotropic gel base

In-Office Directions for use:

  1. Following prophylaxis treatment, fill 1/3 of tray with gel
  2. Insert tray in the patient's mouth
  3. Have patient bite down lightly for 4 minutes
  4. Remove tray(s) and have patient expectorate excess

Advise patient not to eat, drink or rinse for 30 minutes after the application

Home Care Directions for use:

  1. Use only on the advice of a dentist
  2. Apply a thin layer of gel on a toothbrush and brush for up to 4 minutes.
  3. Expectorate and rinse well. Do not eat or drink for 30 minutes after the application.

Medicinal ingredients: Fluoride ions 0.5% w/w (from 1.1% w/w neutral sodium fluoride)

Non-Medicinal Ingredients

INACTIVE INGREDIENT SECTION

Purified water, saccharin sodium, hydroxyethyl cellulose, xylitol, phosphoric acid, sodium hydroxyde

Warnings

WARNINGS AND PRECAUTIONS SECTION

KEEP OUT OF REACH OF CHILDREN

Store at room temperature. Do not expose to excessive heat over 40°C or 104°F

Do not use if seal is broken

Contact Information

SPL UNCLASSIFIED SECTION

Made in USA for AMD Medicom Inc.
2555 Chemin de l’Aviation
Pointe-Claire, Montreal, Quebec, Canada
H9P 2Z2

Questions: 1-800-361-2862

www.medicom.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Panel 1Panel 1

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64778-022064778-0220-1, 64778-0220-3

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML

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
0d1b30d3-e05f-e0de-e063-6394a90a633f5fc8d2ef-737f-2318-e053-2991aa0a2cb52023-12-22WarningsExact identifier
spl set id: 5fc8d2ef-737f-2318-e053-2991aa0a2cb5

Reported adverse events (FAERS/openFDA)#

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