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Denti-Care Denti-Pro Topical Sodium Fluoride

Generic Name: sodium fluoride
Dosage Form: gel

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

2.72 % 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 Directions

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

Carboxymethylcellulose sodium, phosphoric acid, purifed water, saccharin sodium, titanium dioxide, red 33, bubble gum flavour

Warnings

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




DENTI-CARE DENTI-PRO  TOPICAL SODIUM FLUORIDE 60 SECOND
sodium fluoride gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64778-0213
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.0272 g  in 1 mL
Product Characteristics
Color pink Score     
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:64778-0213-3 12 BOTTLE, PLASTIC in 1 CASE
1 NDC:64778-0213-1 480 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/01/1999
Labeler - AMD Medicom Inc. (256880576)
Registrant - AMD Medicom Inc. (256880576)
Revised: 12/2017
 
AMD Medicom Inc.
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