FDA.reportPublic FDA data

Denti-Care Denti-Foam

Manufacturer
AMD Medicom Inc.
Effective date
2020-12-09
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 23:02:59

Label at a glance#

ProductDenti-Care Denti-Foam Topical Sodium Fluoride Grape
Active ingredientSODIUM FLUORIDE
Label structure6 sections

Dosage and administration

Indications: topical anti-caries preparation Directions: Following prophylaxis treatment, fill ¼ of tray with foam To dispense, shake bottle vigorously then invert applicator 180° downward to the bottom of the tray Insert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutes Remove tray and have patient expectorate excess Advise patient not to eat, drink or rinse for 30 minutes after th...

Label contents#

Full prescribing information#

General Information

DESCRIPTION SECTION

AMD Medicom Inc.

DentiCare Pro-Foam

2.72% Topical Sodium Fluoride Foam (1.23% Fluoride Ions)

Grape

4.4 oz / 125 g

NDC 64778-0375-1

NPN 80009738

Rx Only in US

Item code 10037-GR

Indications and Directions

INDICATIONS & USAGE SECTION

Indications: topical anti-caries preparation

Directions:

  1. Following prophylaxis treatment, fill ¼ of tray with foam
  2. To dispense, shake bottle vigorously then invert applicator 180° downward to the bottom of the tray
  3. Insert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutes
  4. Remove tray and have patient expectorate excess

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

Medicinal ingredients: Fluoride ions 1.23% w/w (from 2.72% w/w sodium fluoride)

Non-Medicinal Ingredients

INACTIVE INGREDIENT SECTION

Water, sucralose, sodium phosphate, xylitol, betaine, pluronic, grape flavor

Warnings

WARNINGS AND PRECAUTIONS SECTION

KEEP OUT OF REACH OF CHILDREN. For profesional use only

Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 40°C or 104°F.

Contents under pressure. Do not puncture or incinerate.

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
sodium fluorideACTIVE INGREDIENT8ZYQ1474W71
fluoride ionACTIVE MOIETYQ80VPU408O1

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
64778-037564778-0375-1, 64778-0375-3

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
b60e3e37-96c8-9dac-e053-2a95a90a2d01c92bb4ea-e7e0-49ec-8329-2cc215c35ab82020-12-09WarningsExact identifier
spl id: b60e3e37-96c8-9dac-e053-2a95a90a2d01
spl set id: c92bb4ea-e7e0-49ec-8329-2cc215c35ab8

Reported adverse events (FAERS/openFDA)#

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