Label: CREST PRO-HEALTH INTENSE CLEAN MINT- cetylpyridinium chloride rinse

  • NDC Code(s): 37000-479-05, 37000-479-10, 37000-479-36
  • 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 January 20, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Cetylpyridinium chloride 0.05%

  • 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 (15 wt%), propylene glycol, flavor, poloxamer 407, sucralose, benzoic acid, sodium benzoate, blue 1, yellow 6

  • Questions?

    1–800–285–9139

  • PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label

    COOLING

    SENSATION

    Crest®
    PRO-HEALTH
    CPC ANTIGINGIVITIS/ANTIPLAQUE ORAL MOUTHWASH

    INTENSE

    99% GERM KILL

    CLEAN MINT

    • KEEPS TEETH CLEANER LONGER*
    • FRESHENS BREATH
    • FIGHTS PLAQUE & GINGIVITIS

    See back for important

    ingredient information.

    500 mL

    (16.9 FL OZ)

    479

  • INGREDIENTS AND APPEARANCE
    CREST PRO-HEALTH  INTENSE CLEAN MINT
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-479
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.05 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    ALCOHOL (UNII: 3K9958V90M)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-479-05500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2018
    2NDC:37000-479-101000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2018
    3NDC:37000-479-3636 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/01/2018
    Labeler - The Procter & Gamble Manufacturing Company (004238200)