NEUTRAL TOPICAL- 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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10038-RB Raspberry Foam
DentiCare Pro-Foam 2 % Neutral Topical Sodium Fluoride

General Information

AMD Medicom Inc.

DentiCare Pro-Foam

2% Neutral Topical Sodium Fluoride Foam (0.9% fluoride ion)

Raspberry

4.4 oz / 125 g

NDC 64778-0388-1

NPN 80009615

Rx Only in US

Item code 10038-RB

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 in the patient’s mouth, have patient bite down lightly for 1 minute, up to a maximum of 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 0.9% w/w (from 2% w/w sodium fluoride)

Non-Medicinal Ingredients

water, sucralose, xylitol, betaine, pluronic, raspberry flavor

Warnings

KEEP OUT OF REACH OF CHILDREN. For professional 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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NEUTRAL TOPICAL 
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64778-0388
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 g  in 1 g
Product Characteristics
Color    Score    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64778-0388-312 in 1 CASE12/01/201709/30/2021
1NDC:64778-0388-1125 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 other12/01/200409/30/2021
Labeler - AMD Medicom Inc. (256880576)
Registrant - AMD Medicom Inc. (256880576)

Revised: 12/2020
Document Id: b60e23f9-0639-3796-e053-2a95a90a19f5
Set id: 5fb1a243-8c76-d584-e053-2991aa0ae1cb
Version: 6
Effective Time: 20201209
 
AMD Medicom Inc.