Denti-Care Denti-Rinse

Manufacturer
AMD Medicom Inc.
Effective date
2021-01-27
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 22:54:35

Label at a glance#

ProductDenti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse Berry
Active ingredientSODIUM FLUORIDE
Label structure6 sections

Dosage and administration

Indications: Topical anti-carie solution. Neutral pH is safe for patients with crowns and restorations Directions: Dispense 10mL of solution into a measuring cup. Instruct patient to rinse vigorously for 60 seconds, around and in between teeth, then expectorate. For maximum benefit repeat the rinse procedure with an additional 10mL Advise patient not to eat, drink or rinse for 30 minutes after application Pro-Rins...

Label contents#

Full prescribing information#

General Information

DESCRIPTION SECTION

AMD Medicom Inc.

DentiCare Pro-Rinse

2% Neutral Sodium Fluoride Oral Rinse

Berry

1.9 L / 64 fl oz

NDC 64778-0448-1

NPN 80008542

Rx Only in US

Item code 10044-B

Indications and Directions

INDICATIONS & USAGE SECTION


Indications: Topical anti-carie solution. Neutral pH is safe for patients with crowns and restorations

Directions: Dispense 10mL of solution into a measuring cup. Instruct patient to rinse vigorously for 60 seconds, around and in between teeth, then expectorate. For maximum benefit repeat the rinse procedure with an additional 10mL

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

Pro-Rinse solution may also be applied with a cotton tip applicator to teeth isolated with cotton rolls

Medicinal ingredients: Sodium fluoride 2.0% w/w

Non-Medicinal Ingredients

INACTIVE INGREDIENT SECTION

citric acid, potassium sorbate, purified water, sorbitol, sucralose, red 33, red 40, fruit punch flavour, sodium hydroxide

Warnings

WARNINGS AND PRECAUTIONS SECTION

KEEP OUT OF REACH OF CHILDREN. For professional use only

Not recommended for use by children under 6 years of age. Do not swallow

Store at room temperature. Do not expose to excessive heat over 40ºC or 104ºF

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

DentiCare Pro-Rinse 2% Neutral Sodium Fluoride Oral RinseDentiCare Pro-Rinse 2% Neutral Sodium Fluoride Oral Rinse

FDA-Initiated Inactive NDC Indexing#

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
64778-044864778-0448-1, 64778-0448-3

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
0d1b6293-1a00-ff23-e063-6294a90a245136735906-b49a-4889-94c2-c82eb7314a032023-12-22WarningsExact identifier
spl set id: 36735906-b49a-4889-94c2-c82eb7314a03

Reported adverse events (FAERS/openFDA)#

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