Your browser does not support JavaScript! DENTI-CARE DENTI-PRO TOPICAL SODIUM FLUORIDE 60 SECOND (SODIUM FLUORIDE) GEL [AR MEDICOM INC]
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DENTI-CARE DENTI-PRO TOPICAL SODIUM FLUORIDE 60 SECOND (sodium fluoride) gel
[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-Pro 60 Sec Gel

2.72 % Topical Sodium Fluoride Gel

60 Second Application (1.23 % fluoride ions)

Bubblegum

16.23 fl oz / 480mL

NDC 64778-0213-1

NPN 80008336

Item code 10021-BG

10021Bubblegum




A topical anti-caries preparation. Optimized low pH for penetration. Ideal thixotropic action. Artificially flavoured.

Directions:

1. Use after thorough prophylaxis

2. To dispense, fill tray(s) 1/3 with gel

3. Insert tray(s) in mouth and have patient bite down lightly for 60 seconds

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

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

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

Non-Medicinal ingredients: hydroxyethyl cellulose, phosphoric acid, purified water, red 33, saccharin sodium (anhydrous), titanium dioxide, bubble gum flavour.

Warnings: KEEP OUT OF REACH OF CHILDREN. For professional use only. Do not swallow.

Not recommended for use by children under 18 months of age.

Store at room temperature. Do not expose to excessive heat over 40 degrees C or 104 degrees F.

Do not use if seal is broken.

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

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

UPC 686864010531

No. 112442

Rev.2
DENTI-CARE DENTI-PRO  TOPICAL SODIUM FLUORIDE 60 SECOND
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:64778-0213
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
sodium fluoride (fluoride ion) fluoride ion.0272 g  in 1 mL
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:64778-0213-1480 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/01/1999
Labeler - AR Medicom Inc (247876295)

Revised: 02/2010
Document Id: a017c276-267f-4ff3-84eb-83113b94ff65
Set id: 3b56f852-1eb9-4451-be74-0e5f2ef49983
Version: 1
Effective Time: 20100224
 
AR Medicom Inc

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