Your browser does not support JavaScript! DENTI-CARE DENTI-FOAM TOPICAL SODIUM FLUORIDE RASPBERRY (SODIUM FLUORIDE) AEROSOL, FOAM [AR MEDICOM INC]
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DENTI-CARE DENTI-FOAM TOPICAL SODIUM FLUORIDE RASPBERRY (sodium fluoride) aerosol, foam
[AR Medicom Inc]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

Medicom

Denti-Care

Denti-Foam

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

Raspberry

4.4 oz / 125 g

NDC 64778-0378-1

NPN 80009738

10037Raspberry




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)



Non-Medicinal ingredients: cocamidopropyl betaine, phosphoric acid, poloxamer 407, sucralose, tartaric acid, xylitol, purified water, raspberry flavour

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)

Manufactured in USA for AR Medicom Inc., Montreal, Canada, H8T 3J8

Questions 1-800-361-2862 or www.medicom.com

UPC 686864018704

No. 112484

Item Code 10037-RB

Rev 2
DENTI-CARE DENTI-FOAM  TOPICAL SODIUM FLUORIDE RASPBERRY
sodium fluoride aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:64778-0378
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
sodium fluoride (fluoride ion) fluoride ion.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
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/01/2005
Labeler - AR Medicom Inc (247876295)

Revised: 2/2010
 
AR Medicom Inc

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