DENTI-CARE DENTI-PRO TOPICAL SODIUM FLUORIDE 60 SECOND- sodium fluoride gel 
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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10021-BG Raspberry Gel
DentiCare Pro-Gel 2.72 % Topical Sodium Fluoride Gel 60 sec application

AMD Medicom Inc.

DentiCare Pro-Gel

2.72% Topical Sodium Fluoride Gel

60 Second Application (1.23% fluoride ions)

Raspberry

16.23 fl oz / 480mL

NDC 64778-0218-1

NPN 80008336

RX Only US

Item code 10021-RB

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: Carboxy methyl cellulose sodium, phosphoric acid, water, red dye, blue dye, saccharin sodium, titanium dioxide, raspberry flavor

KEEP OUT OF REACH OF CHILDREN. For professional use only.

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

Store at room temperature. Do not expose to excessive heat over 40ºC or 104ºF.

Do not use if seal is broken.

Made in USA for

AMD Medicom Inc.

2555 Chemin de l'Aviation

Pointe-Claire, Canada, H9P 2Z2

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

Rev.07

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DENTI-CARE DENTI-PRO  TOPICAL SODIUM FLUORIDE 60 SECOND
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64778-0218
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 mL
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorRASPBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64778-0218-1480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/200512/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/01/200512/31/2020
Labeler - AMD Medicom Inc. (256880576)
Registrant - AMD Medicom Inc. (256880576)

Revised: 12/2018
 
AMD Medicom Inc.