Denti-Care Denti-Pro Topical Sodium Fluoride

Generic Name: sodium fluoride gel
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.

Denti-Care Denti-Pro 60 Sec Gel 2.72 % Topical Sodium Fluoride Gel Bubblegum

Medicom

Denti-Care

Denti-Pro 60 Sec Gel

2.72 % Topical Sodium Fluoride Gel

60 Second Application (1.23 % fluoride ions)

Bubblegum

16.23 fl oz / 480mL

NDC 64778-0213-1

NPN 80008336

Item code 10021-BG




A topical anti-caries preparation. Optimized low pH for penetration. Ideal thixotropic action. Artificially flavoured.

Directions:

1. Use after thorough prophylaxis

2. To dispense, fill tray(s) 1/3 with gel

3. Insert tray(s) in mouth and have patient bite down lightly for 60 seconds

4. Remove tray(s) and have patient expectorate excess

5. Advise patient not to eat, drink or rinse for 30 minutes after the application

Medicinal ingredients: Fluoride ions 1.23 % w/w (from 2.72 % w/w sodium fluoride)

Non-Medicinal ingredients: hydroxyethyl cellulose, phosphoric acid, purified water, red 33, saccharin sodium (anhydrous), titanium dioxide, bubble gum flavour.

Warnings: KEEP OUT OF REACH OF CHILDREN. For professional use only. Do not swallow.

Not recommended for use by children under 18 months of age.

Store at room temperature. Do not expose to excessive heat over 40 degrees C or 104 degrees F.

Do not use if seal is broken.

Made in USA for AR Medicom Inc., Montreal, Canada, H8T 3J8

Questions 1-800-361-2862 or www.medicom.com

UPC 686864010531

No. 112442

Rev.2
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 .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:64778-0213-1 480 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 - AR Medicom Inc (247876295)
Revised: 02/2010
 
AR Medicom Inc



Hide
(web3)