DentiCare Pro-Gel

Manufacturer
AMD Medicom Inc | AMD Medicom Inc.
Effective date
2017-12-07
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:29:25

Label at a glance#

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

Dosage and administration

Indications: Topical anti-carie preparation in pH 7 thixotropic gel base . Home Care Directions for use: Use only on the advice of a dentist Apply a thin layer of gel on a toothbrush and brush for up to 4 minutes Expectorate and rinse well Do not eat or drink for 30 minutes after application.

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 ion)

Mint

2 fl oz / 59 mL

NDC 64778-0226-1

NPN 80008841

Rx Only for US

Item code 10022-2M

Indications and Directions

INDICATIONS & USAGE SECTION

Indications: Topical anti-carie preparation in pH 7 thixotropic gel base

.
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 application.

Non-Medicinal Ingredients

INACTIVE INGREDIENT SECTION

water, saccharin sodium, hydroxyethyl cellulose, phosphoric acid, glycerin, spearmint oil, sodium hydroxide

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#

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64778-022664778-0226-1, 64778-0226-3

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
b60e2cfe-aad7-4ee4-e053-2a95a90a96b05fc998a6-497b-7f8e-e053-2a91aa0af51d2020-12-09WarningsExact identifier
spl set id: 5fc998a6-497b-7f8e-e053-2a91aa0af51d

Reported adverse events (FAERS/openFDA)#

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