Denti-Care Denti-Foam Topical Sodium Fluoride Mint

DENTI-CARE DENTI-FOAM TOPICAL SODIUM FLUORIDE MINT- 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.

General Information

AMD Medicom Inc.

DentiCare Pro-Foam

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

Mint

4.4 oz / 125 g

NDC 64778-0376-1

NPN 80009738

Rx Only in US

Item code 10037-M

Indications and Directions

Indications: topical anti-caries preparation

Directions:

1. Following prophylaxis treatment, fill ¼ of tray with foam
2. To dispense, shake bottle vigorously then invert applicator 180° downward to the bottom of the tray
3. Insert tray, have patient bite down lightly for a minimum of 60 seconds, up to 4 minutes
4. 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 phosphateic, xylitol, betaine, pluronic, mint peppermint oil, spearmint oil

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 Pannel

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

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64778-0376 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 MINT Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:64778-0376-3 12 BOTTLE, SPRAY in 1 CASE contains a BOTTLE, SPRAY (64778-0376-1) 1 NDC:64778-0376-1 125 g in 1 BOTTLE, SPRAY This package is contained within the CASE (64778-0376-3)

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)

Revised: 01/2021 AMD Medicom Inc.