DENTICARE PRO-GEL NEUTRAL SODIUM FLUORIDE- sodium fluoride gel

DentiCare Pro-Gel by

Drug Labeling and Warnings

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

Drug Details [pdf]

General Information

AMD Medicom Inc.

DentiCare Pro-Gel

1.1% Neutral Sodium Fluoride Gel for Topical Fluoride Applications (0.5% Fluoride Ions)

Unflavoured / Dye Free

16.23 fl oz / 480mL

NDC: 64778-0220-1

NPN 80008841

RX Only in US

Item code 10022-UN

Indications and Directions

A topical anti-caries preparation in a pH 7 thixotropic gel base

In-Office Directions for use:

1. Following prophylaxis treatment, fill 1/3 of tray with gel
2. Insert tray in the patient's mouth
3. Have patient bite down lightly for 4 minutes
4. Remove tray(s) and have patient expectorate excess

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

Home Care Directions for use:

1. Use only on the advice of a dentist
2. Apply a thin layer of gel on a toothbrush and brush for up to 4 minutes.
3. Expectorate and rinse well. Do not eat or drink for 30 minutes after the application.

Medicinal ingredients: Fluoride ions 0.5% w/w (from 1.1% w/w neutral sodium fluoride)

Non-Medicinal Ingredients

Purified water, saccharin sodium, hydroxyethyl cellulose, xylitol, phosphoric acid, sodium hydroxyde

Warnings

KEEP OUT OF REACH OF CHILDREN

Store at room temperature. Do not expose to excessive heat over 40°C or 104°F

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 Panel

INGREDIENTS AND APPEARANCE

DENTICARE PRO-GEL  NEUTRAL SODIUM FLUORIDE
sodium fluoride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 64778-0220
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.011 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64778-0220-3	12 in 1 CASE	12/01/2017
1	NDC: 64778-0220-1	480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/01/2017

Labeler - AMD Medicom Inc. (256880576)

Registrant - AMD Medicom Inc. (256880576)