Label: AURORA ALCOHOL FREE CLEAN MINT- cetylpyridinium chloride mouthwash

  • NDC Code(s): 63148-553-50
  • Packager: Apollo Health and Beauty Care
  • 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 June 15, 2016

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  • Active ingredient

    Cetylpyridinium Chloride 0.07%

    Purpose

    Antiplaque/Antigingivitis

  • Uses

    • Helps reduce and prevent plaque and gingivitis.
    • Helps control bacteria plaque that contributes 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.

    If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

  • Directions

    • Use after your normal brushing and flossing routein; rinse toothpaste from mouth prior to use.
    • ​Adults and children 6 years of age and 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.
  • Other information

    Store at room temperature.

  • Inactive ingredients

    Water (Aqua), Glycerin, Poloxamer 407, Flavor, Sodium Saccharin, Methylparaben, Sucralose, Propylparaben, Blue 1 (CI 42090).

  • Questions or comments?

    1-866-695-3030

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    AURORA ALCOHOL FREE CLEAN MINT 
    cetylpyridinium chloride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-553
    Route of AdministrationBUCCAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.7 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-553-501000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/14/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/14/2016
    Labeler - Apollo Health and Beauty Care (201901209)
    Registrant - Apollo Health and Beauty Care (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care201901209manufacture(63148-553)
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