DENTI-CARE DENTI-PRO TOPICAL SODIUM FLUORIDE 60 SECOND- sodium fluoride gel 
AMD Medicom Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

10021-GR Grape Gel
DentiCare Pro-Gel 2.72 % Topical Sodium Fluoride Gel 60 sec application

General Information

AMD Medicom Inc.

DentiCare Pro-Gel

2.72% Topical Sodium Fluoride Gel

60 Second Application (1.23% fluoride ions)

Grape

16.23 fl oz / 480mL

NDC 64778-0215-1

NPN 80008336

RX Only in US

Item code 10021-GR

Indication and Directions

Indications: Topical anti-carie preparation

Directions:

  1. Following prophylaxis treatment, Fill 1/3 of tray with gel
  2. Insert tray in the patient’s mouth
  3. Have patient bite down lightly for 60 seconds
  4. Remove tray and have patient expectorate excess

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

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

Non-Medicinal Ingredients

Carboxymethyl cellulose sodium, phosphoric acid, water, saccharin sodium, titanium dioxide, red dye, blue dye, grape flavor

Warnings

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 40°C or 104°F.

Do not use if seal is broken.

Contact Information

Made in USA for AMD Medicom Inc.
2555 Chemin de l’Aviation,
Pointe-Claire, Quebec, Canada
H9P 2Z2

Questions: 1-800-361-2862

www.medicom.com

Principal Display Panel

Panel 1

DENTI-CARE DENTI-PRO  TOPICAL SODIUM FLUORIDE 60 SECOND
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64778-0215
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0272 g  in 1 mL
Product Characteristics
ColorpurpleScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64778-0215-312 in 1 CASE12/01/201708/31/2020
1NDC:64778-0215-1480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/01/199908/31/2020
Labeler - AMD Medicom Inc. (256880576)
Registrant - AMD Medicom Inc. (256880576)

Revised: 1/2021
 
AMD Medicom Inc.