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Denti-care denti-rinse neutral sodium fluoride oral rinse - Medication Information

Product NDC Code 64778-0446
Drug Name

Denti-care denti-rinse neutral sodium fluoride oral rinse

Type Brand
Active Ingredients
Sodium fluoride .02 g/ml
Route DENTAL
Dosage Form LIQUID
RxCUI drug identifier 251960,
991007
Labeler Name AMD Medicom
Packages
Package NDC Code Description
64778-0446-3 12 bottle, pump in 1 case (64778-0446-3) / 1900 ml in 1 bottle, pump (64778-0446-1)
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Description

General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.
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

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Non-Medicinal Ingredients Citric acid, potassium sorbate, purified water, sorbitol, sucralose, blue 1, yellow 5, peppermint flavour, sodium hydroxide

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
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

Spl product data elements

Usually a list of ingredients in a drug product.
Denti-Care Denti-Rinse Neutral Sodium Fluoride Oral Rinse Sodium Fluoride SODIUM FLUORIDE FLUORIDE ION

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Principal Display Panel DentiCare Pro-Rinse 2% Neutral Sodium Fluoride Oral Rinse

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
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

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API