FDA.reportPublic FDA data

Denti-Care Denti-Foam

Manufacturer
AMD Medicom Inc | AMD Medicom Inc.
Effective date
2019-01-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 00:34:54

Label at a glance#

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

Label contents#

Full prescribing information#

DESCRIPTION SECTION

AMD Medicom Inc.

DentiCare Pro-Foam

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

Raspberry

4.4 oz / 125 g

NDC 64778-0378-1

NPN 80009738

Rx Only in US

Item code 10037-RB

DOSAGE & ADMINISTRATION SECTION

A topical anti-caries preparation

Directions (for professional use only):

1. Use after thorough prophylaxis

2. To dispense, shake bottle vigorously then invert applicator 180 degrees downward to the bottom of the tray(s)

Note: fill tray(s) at one quarter full to allow foam to expand

3. Insert tray(s) in mouth and have patient bite down lightly for 1 minute or up to 4 minutes

4. Remove tray(s) and have patient expectorate excess

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

130 applications

Medicinal ingredients:

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

INACTIVE INGREDIENT SECTION

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

WARNINGS AND PRECAUTIONS SECTION

Warnings: KEEP OUT OF REACH OF CHILDREN

Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 40 degrees C or 104 degrees F. Contents under pressure. Do not puncture and incinerate.

Do not use if seal is broken.

Rx (in US only)

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

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
64778-037864778-0378-1

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
7e9203d2-c833-76f0-e053-2a91aa0a305a02486b16-b1a4-4a1d-b7ca-ed77d97e97e42019-01-03WarningsExact identifier
spl id: 7e9203d2-c833-76f0-e053-2a91aa0a305a
spl set id: 02486b16-b1a4-4a1d-b7ca-ed77d97e97e4

Reported adverse events (FAERS/openFDA)#

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