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

DENTI-CARE DENTI-RINSE NEUTRAL SODIUM FLUORIDE ORAL RINSE BERRY- sodium fluoride liquid
AMD 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.

General Information

AMD Medicom Inc.

DentiCare Pro-Rinse

2% Neutral Sodium Fluoride Oral Rinse

Berry

1.9 L / 64 fl oz

NDC 64778-0448-1

NPN 80008542

Rx Only in US

Item code 10044-B

Indications and Directions

Indications: Topical anti-carie solution. Neutral pH is safe for patients with crowns and restorations

Directions: Dispense 10mL of solution into a measuring cup. Instruct patient to rinse vigorously for 60 seconds, around and in between teeth, then expectorate. For maximum benefit repeat the rinse procedure with an additional 10mL

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

Pro-Rinse solution may also be applied with a cotton tip applicator to teeth isolated with cotton rolls

Medicinal ingredients: Sodium fluoride 2.0% w/w

Non-Medicinal Ingredients

citric acid, potassium sorbate, purified water, sorbitol, sucralose, red 33, red 40, fruit punch flavour, sodium hydroxide

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 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, Montreal, Quebec, Canada
H9P 2Z2

Questions: 1-800-361-2862

www.medicom.com

Principal Display Panel

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 0.02 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:64778-0448-3 12 BOTTLE, PUMP in 1 CASE contains a BOTTLE, PUMP (64778-0448-1) 1 NDC:64778-0448-1 1900 mL in 1 BOTTLE, PUMP This package is contained within the CASE (64778-0448-3)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/01/2001

Labeler — AMD Medicom Inc. (256880576)

Registrant — AMD Medicom Inc. (256880576)

Revised: 01/2021 AMD Medicom Inc.