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DentiCare Pro-Foam

Generic Name: sodium fluoride
Dosage Form: aerosol, foam

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.

General Information

AMD Medicom Inc.

DentiCare Pro-Foam

2 % Neutral Topical Sodium Fluoride Foam (0.9 % fluoride ion)

Mint

4.4 oz / 125 g

NDC 64778-0386-1

NPN 80009615

Item code 10038-M

I ndications 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 in the patient’s mouth, have patient bite down lightly for 1 minute, up to a maximum of 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 0.9 % w/w (from 2% w/w sodium fluoride)


Non-Medicinal Ingredients

Non-Medicinal ingredients:

purified water, sucralose, xylitol, cocamidopropyl betaine, pluronic F-127, mint flavour

Warnings

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

Rx Only in US


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

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NEUTRAL TOPICAL 
sodium fluoride aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64778-0386
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.02 g  in 1 g
Product Characteristics
Color      Score     
Shape Size
Flavor MINT Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:64778-0386-1 125 g in 1 BOTTLE, SPRAY
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/01/2004
Labeler - AMD Medicom Inc. (256880576)
Registrant - AMD Medicom Inc. (256880576)
Revised: 12/2017
 
AMD Medicom Inc.
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