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

Denti-Care Denti-Foam by

Drug Labeling and Warnings

Denti-Care Denti-Foam by is a Prescription medication manufactured, distributed, or labeled by AMD Medicom Inc, AMD Medicom Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

AMD Medicom Inc.

DentiCare Pro-Foam

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

Raspberry

4.4 oz / 125 g

NDC: 64778-0378-1

NPN 80009738

Rx Only in US

Item code 10037-RB

DOSAGE & ADMINISTRATION

A topical anti-caries preparation

Directions (for professional use only):

1. Use after thorough prophylaxis

2. To dispense, shake bottle vigorously then invert applicator 180 degrees downward to the bottom of the tray(s)

Note: fill tray(s) at one quarter full to allow foam to expand

3. Insert tray(s) in mouth and have patient bite down lightly for 1 minute or up to 4 minutes

4. Remove tray(s) and have patient expectorate excess

5. Advise patient not to eat, drink or rinse for 30 minutes after the application

130 applications

Medicinal ingredients:

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

INACTIVE INGREDIENT

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

WARNINGS AND PRECAUTIONS

Warnings: KEEP OUT OF REACH OF CHILDREN

Avoid spraying toward open flame. Store at room temperature. Do not expose to excessive heat over 40 degrees C or 104 degrees F. Contents under pressure. Do not puncture and incinerate.

Do not use if seal is broken.

Rx (in US only)

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 64778-0378
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.0272 g  in 1 g

Product Characteristics
Color		Score
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64778-0378-1	125 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/01/2005	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/01/2005	12/31/2020

Labeler - AMD Medicom Inc (256880576)

Registrant - AMD Medicom Inc. (256880576)