FDA Label for Denti-care Denti-rinse Neutral Sodium Fluoride Oral Rinse
View Indications, Usage & Precautions
Denti-care Denti-rinse Neutral Sodium Fluoride Oral Rinse Product Label
The following document was submitted to the FDA by the labeler of this product Amd Medicom. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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
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