FDA Label for Assured Oral Health Fresh Mint
View Indications, Usage & Precautions
Assured Oral Health Fresh Mint Product Label
The following document was submitted to the FDA by the labeler of this product Greenbrier International, Inc.. 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.
Other
For better oral hygiene and fresher breath
Drug Facts
This rinse may cause temporary staining to the surface of the teeth. This is not harmful, and adequate brushing may prevent its occurrence.
*This product is not manufactured or distributed by Proctor & Gamble, distributor of Crest Pro-Health Multi-Protection Alcohol Free Rinse - Refreshing Clean Mint.
DISTRIBUTED BY: GREENBRIER INTERNATIONAL INC.
500 VOLVO PARKWAY, CHESAPEAKE, VA 23320
Otc - Active Ingredient
Active ingredient
Cetylpyridinium chloride 0.07%
Otc - Purpose
Purpose
Antigingivitis, Antiplaque
Indications & Usage
Usehelps control plaque that leads to gingivitis
Warnings
Warnings
Otc - Stop Use
Stop use and ask a dentist if
- gingivitis, bleeding, or redness persists for more than 2 weeks
- you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. These may be symptoms of periodontitis, a serious form of gum disease.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
- adults and children 6 years & older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
- do not swallow
- children 6 to under 12 years of age: supervise use
- when used after brushing. rinse mouth with water first
- children under 6 years of age: do not use
Other Safety Information
Other information
- this rinse is not intended to replace brushing or flossing
Inactive Ingredient
Inactive ingredients water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1
Package Label.Principal Display Panel
COMPARES TO ACTIVE INGREDIENTS OF CREST PRO-HEALTH®*
Assured™
FRESH MINT
ORAL HEALTH RINSE
MULTI-ACTION ALCOHOL-FREE ANTISEPTIC
ANTIGINGIVITIS / ANTIPLAQUE
Kills Germs that Cause Bad Breath, Plaque and the Gum Disease Gingivitis
Alcohol Free, Freshens Breath
16.9 FL OZ (500 mL)
* Please review the disclaimer below.