Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse

Generic Name: sodium fluoride

Dosage Form: oral rinse
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 NDC Product Code (Source) 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

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color green Score      Shape Size Flavor MINT Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 64778-0446-1 1900 mL In 1 BOTTLE, PUMP None

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: 02/2010AR Medicom Inc

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