Label: CREST PRO-HEALTH MULTI-PROTECTION REFRESHING CLEAN MINT- cetylpyridinium chloride rinse

  • NDC Code(s): 37000-451-01, 37000-451-02, 37000-451-03, 37000-451-04, view more
    37000-451-05, 37000-451-06, 37000-451-10
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL

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 June 4, 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, glycerin, flavor, poloxamer 407, methylparaben, sodium saccharin, propylparaben, blue 1

  • Questions?

    1–800–285–9139

  • SPL UNCLASSIFIED SECTION

    Dist. by Procter & Gamble,
    Cincinnati OH 45202

  • PRINCIPAL DISPLAY PANEL - 1 L Bottle Label

    ALCOHOL FREE

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

    MULTI-PROTECTION

    • KILLS GERMS
    • HELPS PREVENT PLAQUE
    • HELPS PREVENT GINGIVITIS
    • KEEPS TEETH CLEANER LONGER
    • FRESHENS BREATH
    • NO BURN OF ALCOHOL

    REFRESHING
    CLEAN MINT

    1 L (33.8 FL OZ)

    99289266

    Principal Display Panel - 1 L Bottle Label
  • INGREDIENTS AND APPEARANCE
    CREST PRO-HEALTH MULTI-PROTECTION  REFRESHING CLEAN MINT
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-451
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.014 g  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorWINTERGREENImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-451-0136 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/03/2011
    2NDC:37000-451-03250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/03/2011
    3NDC:37000-451-04500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/03/2011
    4NDC:37000-451-051000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/03/2011
    5NDC:37000-451-061500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/03/2011
    6NDC:37000-451-102 in 1 PACKAGE02/03/2011
    61000 mL in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:37000-451-02100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35602/03/2011
    Labeler - The Procter & Gamble Manufacturing Company (004238200)