ASSURED ORAL HEALTH FRESH MINT- cetylpyridinium chloride rinse 
Greenbrier International, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Assured Fresh Mint Oral Health Rinse

For better oral hygiene and fresher breath

Drug Facts

Active ingredient
Cetylpyridinium chloride 0.07%

Purpose

Antigingivitis, Antiplaque

Usehelps control plaque that leads to gingivitis

Warnings

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.

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

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

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)

Assured FM OH Rinse Front

Assured FM OH Rinse Back

ASSURED  ORAL HEALTH FRESH MINT
cetylpyridinium chloride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0320
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.07 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
WATER (UNII: 059QF0KO0R)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
POLOXAMER 188 (UNII: LQA7B6G8JG)  
GLYCERIN (UNII: PDC6A3C0OX)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-0320-7500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/21/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35610/21/2019
Labeler - Greenbrier International, Inc. (610322518)

Revised: 8/2021
Document Id: ca3f1b08-986a-0e50-e053-2a95a90a8b45
Set id: 9571bc73-d1c5-4550-e053-2a95a90a886b
Version: 3
Effective Time: 20210823
 
Greenbrier International, Inc.