10044-m Mint Rinse

10044-m Mint Rinse
SPL v7
SPL
SPL Set ID 1da64824-9389-4109-bea9-b91600caf023
Route
DENTAL
Published
Effective Date 2020-04-27
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (0.02 g)

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2001-03-01

Description

AMD Medicom Inc. DentiCare Pro-Rinse 2% Neutral Sodium Fluoride Oral Rinse Mint 1.9 L / 64 fl oz NDC 64778-0446-1 NPN 80008542 Item code 10044-M


Medication Information

Description

AMD Medicom Inc. DentiCare Pro-Rinse 2% Neutral Sodium Fluoride Oral Rinse Mint 1.9 L / 64 fl oz NDC 64778-0446-1 NPN 80008542 Item code 10044-M

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

Rx Only in US



Made in USA for AMD Medicom Inc.

2555 Chemin de l’Aviation,

Pointe-Claire, Quebec, Canada

H9P 2Z2

Questions: 1-800-361-2862



www.medicom.com

General Information

AMD Medicom Inc.





DentiCare Pro-Rinse



2% Neutral Sodium Fluoride Oral Rinse

Mint



1.9 L / 64 fl oz



NDC 64778-0446-1



NPN 80008542







Item code 10044-M

Principal Display Panel



Non Medicinal Ingredients

Citric acid, potassium sorbate, purified water, sorbitol, sucralose, blue 1, yellow 5, peppermint flavour, sodium hydroxide

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


Structured Label Content

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

Rx Only in US



Made in USA for AMD Medicom Inc.

2555 Chemin de l’Aviation,

Pointe-Claire, Quebec, Canada

H9P 2Z2

Questions: 1-800-361-2862



www.medicom.com

General Information

AMD Medicom Inc.





DentiCare Pro-Rinse



2% Neutral Sodium Fluoride Oral Rinse

Mint



1.9 L / 64 fl oz



NDC 64778-0446-1



NPN 80008542







Item code 10044-M

Principal Display Panel



Non Medicinal Ingredients (Non-Medicinal Ingredients)

Citric acid, potassium sorbate, purified water, sorbitol, sucralose, blue 1, yellow 5, peppermint flavour, sodium hydroxide

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


Advanced Ingredient Data


Raw Label Data

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