DENTI-CARE DENTI-FOAM TOPICAL SODIUM FLUORIDE STRAWBERRY- sodium fluoride aerosol, foam
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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10037-ST Strawberry Foam
DentiCare Pro-Foam 2.72 % Topical Sodium Fluoride

General Information

AMD Medicom Inc.

DentiCare Pro-Foam

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

Strawberry

4.4 oz / 125 g

NDC 64778-0379-1

NPN 80009738

Rx Only in US

Item code 10037-ST

Indications and Directions

Indications: topical anti-caries preparation

Directions:

Following prophylaxis treatment, fill ¼ of tray with foam
To dispense, shake bottle vigorously then invert applicator 180° downward to the bottom of the tray
Insert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutes
Remove tray and have patient expectorate excess

Advise patient not to eat, drink or rinse for 30 minutes after the treatment

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

Non-Medicinal Ingredients

Water, sucralose, sodium phosphate, xylitol, betaine, pluronic, strawberry flavor

Warnings

KEEP OUT OF REACH OF CHILDREN. For professional use only

Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 40°C or 104°F

Contents under pressure. Do not puncture or incinerate

Do not use if seal is broken.

Contact Information

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

Questions: 1-800-361-2862

www.medicom.com

Principal Display Panel

Panel 1

DENTI-CARE DENTI-FOAM TOPICAL SODIUM FLUORIDE STRAWBERRY
sodium fluoride aerosol, foam

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:64778-0379
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 g

Product Characteristics
Color		Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64778-0379-3	12 in 1 CASE	12/01/2017	05/31/2024
1	NDC:64778-0379-1	125 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		05/01/2003	05/31/2024

Labeler - AMD Medicom Inc (256880576)

Registrant - AMD Medicom Inc. (256880576)

Revised: 12/2023

Document Id: 0d1b475e-5784-2bd1-e063-6294a90a7311

Set id: 1bc6f926-b304-4ca4-9ebf-06868782b4ec

Version: 7

Effective Time: 20231222

AMD Medicom Inc