Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse

Generic Name: sodium fluoride
Dosage Form: oral rinse

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-Rinse 2 % Neutral Sodium Fluoride Oral Rinse Mint

Medicom

Denti-Care

Denti-Rinse

2% Neutral Sodium Fluoride Oral Rinse

Mint

1.9 L / 64 fl oz

NDC 64778-0446-1

NPN 80008542

Rx Only




For topical application to aid in the prevention of dental caries. Neutral pH is especially safe for crowns and restorations.

Directions:

1. Dispense 10mL of Denti-Rinse 2% Neutral Sodium Fluoride solution into a measuring cup.

2. Instruct patient to rinse vigorously for 1 minute with 10mL of the solution around and between teeth, and then expectorate.

3. For maximum benefit, repeat the rinse procedure with an additional 10mL.

4. Instruct patient not to eat, drink or rinse mouth for at least 30 minutes.

5. Denti-Rinse solution may also be applied full strength with a cotton tip applicator to teeth isolated with cotton rolls.


Medicinal ingredients: Sodium fluoride 2.0% w/w



Non-Medicinal ingredients: Citric acid (anhydrous), potassium sorbate, purified water, sorbitol, sucralose, blue 1, yellow 5, peppermint flavour

Warnings: KEEP OUT OF REACH OF CHILDREN. For professional use only.

Not recommended for use by children under 6 years of age. Do not swallow.

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: A.R. Medicom Inc. Montreal, Canada H8T 3J8

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

Item Code 10044-M

UPC 686864000709

No. 112450

Rev.2

DENTI-CARE DENTI-RINSE  NEUTRAL SODIUM FLUORIDE ORAL RINSE
sodium fluoride liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64778-0446
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sodium fluoride (fluoride ion) fluoride ion .02 g  in 1 mL
Product Characteristics
Color green Score     
Shape Size
Flavor MINT Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:64778-0446-1 1900 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/01/2001
Labeler - AR Medicom Inc (247876295)
Revised: 02/2010
 
AR Medicom Inc



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