The following Structured Product Label (SPL) was submitted to the FDA by Greenbrier International, Inc. for the product Assured (NDC 33992-0320). 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 other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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
Active ingredient
Cetylpyridinium chloride 0.07%
Purpose
Antigingivitis, Antiplaque
Usehelps control plaque that leads to gingivitis
Warnings
Stop use and ask a dentist if
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.
Directions
Other information
Inactive ingredients water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, sucralose, benzoic acid, blue 1
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.
