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

Denti-Care Denti-Rinse by

Drug Labeling and Warnings

Denti-Care Denti-Rinse by is a Prescription medication manufactured, distributed, or labeled by AMD Medicom Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	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	Marketing Start Date	Marketing End Date
1	NDC: 64778-0448-3	12 in 1 CASE	12/01/2017
1	NDC: 64778-0448-1	1900 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

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)