Denti-Care Denti-Pro
- Manufacturer
- AMD Medicom Inc.
- Effective date
- 2018-12-30
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:36:23
Label at a glance#
ProductDenti-Care Denti-Pro Topical Sodium Fluoride 60 Second
Active ingredientSODIUM FLUORIDE
Label structure6 sections
Contacts and useful links#
Websitewww.medicom.com
www.medicom.com
www.medicom.comLabel contents#
Full prescribing information#
DESCRIPTION SECTION
AMD Medicom Inc.
DentiCare Pro-Gel
2.72% Topical Sodium Fluoride Gel
60 Second Application (1.23% fluoride ions)
Cherry
16.23 fl oz / 480mL
NDC 64778-0214-1
NPN 80008336
RX Only US
Item code 10021-CH
DOSAGE & ADMINISTRATION SECTION
A topical anti-caries preparation. Optimized low pH for penetration. Ideal thixotropic action. Artificially flavoured.
Directions:
1. Use after thorough prophylaxis
2. To dispense, fill tray(s) 1/3 with gel
3. Insert tray(s) in mouth and have patient bite down lightly for 60 seconds
4. Remove tray(s) and have patient expectorate excess
5. Advise patient not to eat, drink or rinse for 30 minutes after the application
Medicinal ingredients: Fluoride ions 1.23% w/w (from 2.72% w/w sodium fluoride)
INACTIVE INGREDIENT SECTION
Non-Medicinal ingredients: Carboxy methyl cellulose sodium, phosphoric acid, water, red dye, saccharin sodium, titanium dioxide, cherry flavor
WARNINGS AND PRECAUTIONS SECTION
KEEP OUT OF REACH OF CHILDREN. For professional use only.
Not recommended for use by children under 18 months of age.
Store at room temperature. Do not expose to excessive heat over 40ºC or 104ºF.
Do not use if seal is broken.
SPL UNCLASSIFIED SECTION
Made in USA for
AMD Medicom Inc.
2555 Chemin de l'Aviation
Pointe-Claire, Canada, H9P 2Z2
Questions 1-800-361-2862 or www.medicom.com
Rev.07
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| sodium fluoride | ACTIVE INGREDIENT | 8ZYQ1474W7 | 1 | |
| fluoride ion | ACTIVE MOIETY | Q80VPU408O | 1 |
Products#
Every source-derived product name is available through these pages.
- Denti-Care Denti-Pro Topical Sodium Fluoride 60 Second
- Sodium Fluoride
- FLUORIDE ION
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 64778-0214 | 64778-0214-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SODIUM FLUORIDE | 8ZYQ1474W7 | ACTIM |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 7e40fae9-b3eb-49c9-e053-2991aa0a21b3 | 05af0929-6a37-4b76-b3f9-94ccd8a3a17b | 2018-12-30 | Warnings | 7e40fae9-b3eb-49c9-e053-2991aa0a21b3 05af0929-6a37-4b76-b3f9-94ccd8a3a17b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.