Label: SHOPKO ALCOHOL FREE MULTI ACTION- cetylpyridinium chloride mouthwash

  • 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 8, 2018

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  • Active ingredient

    Cetylpyridinium Chloride 0.07%

    Purpose

    Antigingivitis/Antiplaque

  • Uses

    • helps reduce plaque that lead to:
    • gingivitis
    • bleeding gums
  • Warnings

    Stop use and ask a dentist if

    • gingivitis, bleeding, or redness persists for more than 2 weeks
    • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

    Keep out of reach of children under 6 years of age.

    If more than used for rinsing is accidentally swalowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow the rinse.
    • Children 6 years to under 12 years of age: supervise use.
    • Children under 6 years of age: do not use.
  • Other information

    • this rinse is not intended to replace brushing or flossing.
    • store at room temperature.
  • Inactive ingredients

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

  • Questions ro comments?

    1-866-695-3030

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    SHOPKO ALCOHOL FREE MULTI ACTION 
    cetylpyridinium chloride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-010
    Route of AdministrationORAL
    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:63148-010-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/07/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/07/2018
    Labeler - Apollo Health and Beauty Care Inc. (201901209)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(63148-010)
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