Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse Berry

DENTI-CARE DENTI-RINSE NEUTRAL SODIUM FLUORIDE ORAL RINSE BERRY- sodium fluoride liquid
AR Medicom Inc

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.

Medicom
Denti-Care
Denti-Rinse
2% Neutral Sodium Fluoride Oral Rinse
Berry
1.9 L / 64 fl oz
NDC 64778-0448-1
NPN 80008542
Rx Only
10044Berry
(click image for full-size original)

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, red 33, red 40, fruit punch 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-B

UPC 686864000693

No. 112449

Rev.2

DENTI-CARE DENTI-RINSE NEUTRAL SODIUM FLUORIDE ORAL RINSE BERRY sodium fluoride liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64778-0448
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 pink Score
Shape Size
Flavor BERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64778-0448-1 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 06/01/2001
Labeler — AR Medicom Inc (247876295)

Revised: 02/2010 AR Medicom Inc

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