DENTI-CARE DENTI-PRO TOPICAL SODIUM FLUORIDE 60 SECOND- sodium fluoride gel

Denti-Care Denti-Pro by

Drug Labeling and Warnings

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

Drug Details [pdf]

DESCRIPTION

AMD Medicom Inc.

DentiCare Pro-Gel

2.72% Topical Sodium Fluoride Gel

60 Second Application (1.23% fluoride ions)

Raspberry

16.23 fl oz / 480mL

NDC: 64778-0218-1

NPN 80008336

RX Only US

Item code 10021-RB

DOSAGE & ADMINISTRATION

A topical anti-caries preparation. Optimized low pH for penetration. Ideal thixotropic action. Artificially flavoured.

Directions:

1. Use after thorough prophylaxis

2. To dispense, fill tray(s) 1/3 with gel

3. Insert tray(s) in mouth and have patient bite down lightly for 60 seconds

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

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

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

INACTIVE INGREDIENT

Non-Medicinal ingredients: Carboxy methyl cellulose sodium, phosphoric acid, water, red dye, blue dye, saccharin sodium, titanium dioxide, raspberry flavor

WARNINGS AND PRECAUTIONS

KEEP OUT OF REACH OF CHILDREN. For professional use only.

Not recommended for use by children under 18 months of age.

Store at room temperature. Do not expose to excessive heat over 40ºC or 104ºF.

Do not use if seal is broken.

SPL UNCLASSIFIED SECTION

Made in USA for

AMD Medicom Inc.

2555 Chemin de l'Aviation

Pointe-Claire, Canada, H9P 2Z2

Questions 1-800-361-2862 or www.medicom.com

Rev.07

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DENTI-CARE DENTI-PRO  TOPICAL SODIUM FLUORIDE 60 SECOND
sodium fluoride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 64778-0218
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 mL

Product Characteristics
Color	pink	Score
Shape		Size
Flavor	RASPBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64778-0218-1	480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2005	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/01/2005	12/31/2020

Labeler - AMD Medicom Inc. (256880576)

Registrant - AMD Medicom Inc. (256880576)