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DentiCare Pro-Gel Prescribing Information

Package insert / product label
Generic name: sodium fluoride
Dosage form: gel
Drug class: Mouth and throat products

Medically reviewed by Drugs.com. Last updated on Aug 24, 2023.

The DentiCare Pro-Gel brand name has been discontinued in the U.S. If generic versions of this product have been approved by the FDA, there may be generic equivalents available.

DentiCare Pro-Gel Description

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 Usage for DentiCare Pro-Gel

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 and Precautions

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

Panel 1

NEUTRAL SODIUM FLUORIDE
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64778-0239
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.02 g in 1 mL
Product Characteristics
ColorredScore
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64778-0239-312 in 1 CASE12/01/2017
1NDC:64778-0239-1480 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 other02/23/2017
Labeler - AMD Medicom Inc. (256880576)
Registrant - AMD Medicom Inc. (256880576)

Medical Disclaimer