Label: CREST PRO HEALTH- 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 November 4, 2019

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  • Drug Facts

  • Active ingredient 

    Cetylpyridinium chloride 0.07%

    Purpose

    Antigingivitis/antiplaque

  • Uses

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

    Ask a dentist if

    symptoms persist or condition worsens after regular use.

    Keep out of reach of children.

    under 6 yrs. 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; 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 to 12 yrs. of age: supervise use
    • children under 6 yrs. of age: do not use
  • Inactive ingredients

    water, glycerin, flavor, poloxamer 407, sodium saccharin, methylparaben, sucralose, propylparaben, blue 1

  • Questions or comments?

    1-800-285-9139

  • Package Labeling:

    Label8

  • INGREDIENTS AND APPEARANCE
    CREST PRO HEALTH 
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67751-186(NDC:37000-451)
    Route of AdministrationTOPICAL
    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)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    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:67751-186-0136 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/04/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35612/04/2017
    Labeler - Navajo Manufacturing Company Inc. (091917799)
    Establishment
    NameAddressID/FEIBusiness Operations
    Navajo Manufacturing Company Inc.136941411relabel(67751-186) , repack(67751-186)
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