DENTICARE PRO-GEL 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.

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10022-UN Unflavored Gel
DentiCare Denti-Pro 1.1 % Neutral Sodium Fluoride

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

Panel 1

DENTICARE PRO-GEL  NEUTRAL SODIUM FLUORIDE
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64778-0220
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.011 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64778-0220-312 in 1 CASE12/01/201705/31/2023
1NDC:64778-0220-1480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/01/201705/31/2023
Labeler - AMD Medicom Inc. (256880576)
Registrant - AMD Medicom Inc. (256880576)

Revised: 12/2023
Document Id: 0d1b30d3-e05f-e0de-e063-6394a90a633f
Set id: 5fc8d2ef-737f-2318-e053-2991aa0a2cb5
Version: 3
Effective Time: 20231222
 
AMD Medicom Inc.