Skip to main content

Denti-Care Denti-Pro Topical Sodium Fluoride 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 Jan 18, 2024.

Denti-Care Denti-Pro Topical Sodium Fluoride Description

AMD Medicom Inc.

DentiCare Pro-Gel

2.72% Topical Sodium Fluoride Gel

60 Second Application (1.23 % fluoride ions)

Bubble Gum

16.23 fl oz / 480mL

NDC 64778-0213-1

NPN 80008336

RX only in US

Item code 10021-BG

Indications and Usage for Denti-Care Denti-Pro Topical Sodium Fluoride

Indications: Topical anti-carie preparation

Directions:

  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 60 seconds
  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 1.23% w/w (from 2.72% w/w sodium fluoride)

Non-Medicinal Ingredients

Carboxy methyl cellulose sodium, phosphoric acid, water, saccharin sodium, titanium dioxide, red dye, bubble gum flavor

Warnings and Precautions

KEEP OUT OF REACH OF CHILDREN. For professional use only. Not recommended for children under 18 months of age

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, Quebec, Canada
H9P 2Z2

Questions: 1-800-361-2862


www.medicom.com

Principal Display Panel

Panel 1

DENTI-CARE DENTI-PRO TOPICAL SODIUM FLUORIDE 60 SECOND
sodium fluoride gel
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64778-0213
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0272 g in 1 mL
Product Characteristics
ColorpinkScore
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64778-0213-312 in 1 CASE12/01/2017
1NDC:64778-0213-1480 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 other12/01/1999
Labeler - AMD Medicom Inc. (256880576)
Registrant - AMD Medicom Inc. (256880576)

Medical Disclaimer