Label: CREST PRO-HEALTH GUM AND BREATH PURIFY- cetylpyridinium chloride rinse

  • NDC Code(s): 37000-949-01
  • 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 0.07%

  • 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, zinc lactate, methylparaben, sodium saccharin, sucralose, propylparaben, poloxamer 407, blue 1

  • Questions?

    1-800-285-9139

  • SPL UNCLASSIFIED SECTION

    DISTR. BY PROCTER & GAMBLE,

    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 1 L Bottle Label

    Crest®

    PRO-HEALTH™

    CPC Antigingivitis/Antiplaque Oral Rinse
    GUM

    AND

    BREATH PURIFY

    HELPS PREVENT BAD BREATH, CLINICALLY PROVEN HEALTHIER GUMS*

    GUM DEFENSE

    • Reduces Gum Swelling & Redness
    • Protects Against Gingivitis at the Gum Line

    + Breath Fighter

    SMOOTH MINT

    1 L (33.8 FL OZ)

    949

  • INGREDIENTS AND APPEARANCE
    CREST PRO-HEALTH  GUM AND BREATH PURIFY
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-949
    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)  
    ZINC LACTATE (UNII: 2GXR25858Y)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-949-011000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35601/31/2020
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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