Label: CREST PRO-HEALTH- cetylpyridinium chloride rinse

  • NDC Code(s): 37000-452-03, 37000-452-04
  • Packager: The Procter & Gamble Manufacturing Company
  • 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 February 12, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Cetylpyridinium chloride 0.07%

  • Purpose

    Antigingivitis/Antiplaque

  • Uses

    • helps prevent and reduce plaque and gingivitis
    • helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums
  • Warnings

    Ask a dentist if symptoms persist or condition worsens after regular use.

    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

    • use after your normal brushing and flossing routine; rinse toothpaste from mouth prior to use
    • adults and children 6 yrs. & older: Rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
      • do not swallow
      • children 6 years to under 12 years of age: supervise use
    • children under 6 years of age: do not use
  • Inactive ingredients

    water, alcohol (10.8 wt%), glycerin, propylene glycol, flavor, poloxamer 407, sodium saccharin, yellow 6, green 3

  • Questions?

    1–800–285–9139

  • PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

    24HR
    PROTECTION*

    USE 2X/ DAY

    Crest®
    PRO-HEALTH™
    CPC ANTIGINGIVITIS/ANTIPLAQUE ORAL RINSE

    NEW!

    INVIGORATING CLEAN
    MULTI-PROTECTION

    *FIGHTS PLAQUE & GINGIVITIS

    • KILLS GERMS
    • REDUCES PLAQUE
    • HELPS PREVENT GINGIVITIS
    • KEEPS TEETH CLEANER LONGER†
    • FRESHENS BREATH
    • INVIGORATING SENSATION

    FPO

    INVIGORATING MINT

    SEE BACK FOR IMPORTANT
    INGREDIENT INFORMATION

    500 mL (16.9 FL OZ)

    99629062

    Principal Display Panel - 500 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    CREST PRO-HEALTH 
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-452
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.014 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorWINTERGREENImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-452-03500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/14/201109/10/2017
    2NDC:37000-452-041000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/14/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/14/2011
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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