NEUTRAL SODIUM FLUORIDE- sodium fluoride gel

Neutral Sodium Fluoride by

Drug Labeling and Warnings

Neutral Sodium Fluoride 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

2% Neutral Sodium Fluoride Gel

Topical Fluoride Applications (0.9% Fluoride Ions)

Strawberry

16.23 fl oz / 480 mL

NDC: 64778-0239-1

NPN 80008850

Rx Only for US

Item Code 10023-ST

Indications and Directions

Indications: Topical anti-carie preparation in a pH 7 thixotropic gel base.

Directions:

1. Following prophylaxis treatment, fll 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 and have patient expectorate excess

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

Medicinal ingredients: Fluoride ions 0.9% w/w (from 2% w/w neutral sodium Fluoride)

Non-Medicinal Ingredients

Water, saccharin sodium, hydroxyethyl cellulose, phosphoric acid, red dye, Strawberry flavor, sodium hydroxide

Warnings

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

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

Do not use if seal is broken.

Contact Information

Made in USA for AMD Medicom Inc.
2555 Chemin de l’Aviation
Pointe-Claire, Montreal, Quebe, Canada
H9P 2Z2

Questions: 1-800-361-2862

www.medicom.com

Prinicipal Display Panel

INGREDIENTS AND APPEARANCE

NEUTRAL SODIUM FLUORIDE 
sodium fluoride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 64778-0239
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.02 g  in 1 mL

Product Characteristics
Color	red	Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64778-0239-3	12 in 1 CASE	12/01/2017
1	NDC: 64778-0239-1	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		02/23/2017

Labeler - AMD Medicom Inc. (256880576)

Registrant - AMD Medicom Inc. (256880576)