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 Bubble Gum 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)

Bubble Gum

16.23 fl oz / 480mL

NDC 64778-0213-1

NPN 80008336

RX only in US

Item code 10021-BG

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 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, red dye, bubble gum flavor

Warnings

KEEP OUT OF REACH OF CHILDREN. For professional use only. Not recommended for 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:64778-0213
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	pink	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64778-0213-3	12 in 1 CASE	12/01/2017	10/31/2020
1	NDC:64778-0213-1	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		12/01/1999	10/31/2020

Labeler - AMD Medicom Inc. (256880576)

Registrant - AMD Medicom Inc. (256880576)

Revised: 12/2020

Document Id: b60e1d59-0d3d-137c-e053-2a95a90a7c2a

Set id: 3b56f852-1eb9-4451-be74-0e5f2ef49983

Version: 6

Effective Time: 20201209