DENTI-CARE DENTI-FOAM TOPICAL SODIUM FLUORIDE RASPBERRY- 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-RB Raspberry Foam
DentiCare Pro-Foam 2.72 % Topical Sodium Fluoride

AMD Medicom Inc.

DentiCare Pro-Foam

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

Raspberry

4.4 oz / 125 g

NDC 64778-0378-1

NPN 80009738

Rx Only in US

Item code 10037-RB

A topical anti-caries preparation

Directions (for professional use only):

1. Use after thorough prophylaxis

2. To dispense, shake bottle vigorously then invert applicator 180 degrees downward to the bottom of the tray(s)

Note: fill tray(s) at one quarter full to allow foam to expand

3. Insert tray(s) in mouth and have patient bite down lightly for 1 minute or up to 4 minutes

4. Remove tray(s) and have patient expectorate excess

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

130 applications

Medicinal ingredients:

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


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

Warnings: KEEP OUT OF REACH OF CHILDREN

Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 40 degrees C or 104 degrees F. Contents under pressure. Do not puncture and incinerate.

Do not use if seal is broken.

Rx (in US only)

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

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DENTI-CARE DENTI-FOAM  TOPICAL SODIUM FLUORIDE RASPBERRY
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64778-0378
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
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64778-0378-1125 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/01/200512/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/01/200512/31/2020
Labeler - AMD Medicom Inc (256880576)
Registrant - AMD Medicom Inc. (256880576)

Revised: 1/2019
Document Id: 7e9203d2-c833-76f0-e053-2a91aa0a305a
Set id: 02486b16-b1a4-4a1d-b7ca-ed77d97e97e4
Version: 4
Effective Time: 20190103
 
AMD Medicom Inc