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-M Mint Gel
DentiCare Pro-Gel 2.72 % Topical Sodium Fluoride Gel 60 sec application

General Information

AMD Medicom Inc.

DentiCare Pro-Gel

2.72% Topical Sodium Fluoride Gel

60 Second Application (1.23% fluoride ions)

Mint

16.23 fl oz / 480mL

NDC 64778-0216-1

NPN 80008336

RX Only US

Item code 10021-M

Indications and Directions

Indications: Topical anti-carie preparation

Directions:

Following prophylaxis treatment, fill 1/3 of tray with gel
Insert tray in the patient's mouth
Have patient bite down lightly for 60 seconds
Remove tray and have patient expectorate excess

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, saccharin sodium, titanium dioxide, blue dye, yellow dye, peppermint oil, spearmint oil

Warnings

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.

Contact Information

Made in USA for AMD Medicom Inc.
2555 Chemin de l’Aviation
Pointe-Claire, Quebec, Canada
H9P 2Z2

Questions: 1-800-361-2862

www.medicom.com

Principal Display Panel

Panel 1

DENTI-CARE DENTI-PRO TOPICAL SODIUM FLUORIDE 60 SECOND
sodium fluoride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:64778-0216
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.0272 g in 1 mL

Product Characteristics
Color	green	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64778-0216-3	12 in 1 CASE	12/01/2017	03/31/2023
1	NDC:64778-0216-1	480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		10/01/1999	03/31/2023

Labeler - AMD Medicom Inc. (256880576)

Registrant - AMD Medicom Inc. (256880576)

Revised: 12/2023

Document Id: 0d1b1703-d196-f2cc-e063-6294a90a703a

Set id: e503767f-7452-4114-bbf8-29c5035a0793

Version: 7

Effective Time: 20231222