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Denti-Care Denti-Foam Topical Sodium Fluoride Foam

Generic Name: sodium fluoride
Dosage Form: aerosol, foam

Medically reviewed on Dec 1, 2017

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

DentiCare

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

Bubblegum

4.4 oz / 125 g

NDC 64778-0373-1

NPN 80009738

Item code 10037-BG

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

Non-Medicinal ingredients:

purified water, sucralose, sodium phosphate monobasic, xylitol, cocamidopropyl betaine, poloxamer 407, bubblegum 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 and incinerate.

Do not use if seal is broken.

Rx (in US only)

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

Principal Display Panel




DENTI-CARE DENTI-FOAM  TOPICAL SODIUM FLUORIDE BUBBLE GUM
sodium fluoride aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64778-0373
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.0272 g  in 1 g
Product Characteristics
Color      Score     
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:64778-0373-1 125 g in 1 BOTTLE, SPRAY
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 05/01/2003
Labeler - AMD Medicom Inc. (256880576)
Registrant - AMD Medicom Inc. (256880576)
 
AMD Medicom Inc.
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