Neutral Sodium Fluoride: Package Insert and Label Information

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

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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.

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