Label: ASSURED ORAL HEALTH FRESH MINT- cetylpyridinium chloride rinse

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated August 23, 2021

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  • SPL UNCLASSIFIED SECTION

    For better oral hygiene and fresher breath

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient
    Cetylpyridinium chloride 0.07%

  • PURPOSE

    Purpose

    Antigingivitis, Antiplaque

  • INDICATIONS & USAGE

    Usehelps control plaque that leads to gingivitis

  • WARNINGS

    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.

  • 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

  • SPL UNCLASSIFIED SECTION

    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

  • 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)

    Assured FM OH Rinse Front

    Assured FM OH Rinse Back

  • INGREDIENTS AND APPEARANCE
    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)
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