Neutral Sodium Fluoride

NEUTRAL SODIUM FLUORIDE- sodium fluoride gel
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-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

NEUTRAL SODIUM FLUORIDE sodium fluoride gel

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM FLUORIDE (FLUORIDE ION) 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 Multilevel Packaging 1 NDC:64778-0239-3 12 BOTTLE, PLASTIC in 1 CASE contains a BOTTLE, PLASTIC (64778-0239-1) 1 NDC:64778-0239-1 480 mL in 1 BOTTLE, PLASTIC This package is contained within the CASE (64778-0239-3)

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)

Revised: 01/2021 AMD Medicom Inc.