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
Denti-care Denti-rinse Liquid
FDA Label NDC 64778-0446
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Amd Medicom for the product Denti-care Denti-rinse (NDC 64778-0446). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding general information, indications and directions, non-medicinal ingredients, warnings, contact information, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Non-Medicinal Ingredients
Citric acid, potassium sorbate, purified water, sorbitol, sucralose, blue 1, yellow 5, peppermint 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 40°C or 104°F.
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
Principal Display Panel
* Please review the disclaimer below.
