DENTI-CARE DENTI-FOAM TOPICAL SODIUM FLUORIDE GRAPE- sodium fluoride aerosol, foam 
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.

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10037-GR Grape Foam
DentiCare Pro-Foam 2.72 % Topical Sodium Fluoride

General Information

AMD Medicom Inc.

DentiCare Pro-Foam

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

Grape

4.4 oz / 125 g

NDC 64778-0375-1

NPN 80009738

Rx Only in US

Item code 10037-GR

Indications and Directions

Indications: topical anti-caries preparation

Directions:

  1. Following prophylaxis treatment, fill ¼ of tray with foam
  2. To dispense, shake bottle vigorously then invert applicator 180° downward to the bottom of the tray
  3. Insert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutes
  4. Remove tray and have patient expectorate excess

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

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

Non-Medicinal Ingredients

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

Warnings

KEEP OUT OF REACH OF CHILDREN. For profesional use only

Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 40°C or 104°F.

Contents under pressure. Do not puncture or incinerate.

Do not use if seal is broken.

Contact Information

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

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DENTI-CARE DENTI-FOAM  TOPICAL SODIUM FLUORIDE GRAPE
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64778-0375
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 g
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64778-0375-312 in 1 CASE12/01/201712/31/2021
1NDC:64778-0375-1125 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/01/200312/31/2021
Labeler - AMD Medicom Inc. (256880576)
Registrant - AMD Medicom Inc. (256880576)

Revised: 12/2020
Document Id: b60e3e37-96c8-9dac-e053-2a95a90a2d01
Set id: c92bb4ea-e7e0-49ec-8329-2cc215c35ab8
Version: 6
Effective Time: 20201209
 
AMD Medicom Inc.