Label: ANTIGINGIVITIS/ANTIPLAQUE- 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 September 23, 2022

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  • SPL UNCLASSIFIED SECTION

    Kroger

    Smooth Mint

    KILLS THE GERMS THAT CAUSE BAD BREATH

  • Active Ingredient

    Cetylpyridinium Chloride 0.07%

  • Purpose

    Antigingivitis, Antiplaque

  • Use

    helps control plaque {bacteria} that leads to gingivitis

  • Warnings

    For this product

  • 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 increased 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 swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ adults and children 6 years & 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
    ■ when used after brushing, rinse mouth with water first
    ■ children under 6 years of age: do not use

  • Other information

    ■ this rinse is not intended to replace brushing or flossing

  • Inactive ingredients

    water, glycerin, flavor, zinc lactate, benzoic acid, sodium saccharin, sucralose, sodium benzoate, poloxamer 407, blue 1

  • Questions?

    Call 1-800-632-6900

  • SPL UNCLASSIFIED SECTION

    This may cause temporary staining to the surface of teeth.

    This is not harmful, and adequate brushing may prevent its occurrence.

    Crest Pro-Health is a register trademark of the Proctor & Gamble Co., Cincinnati, OH

    45202. The Proctor and Gamble Co. is not affiliated with thE Kroger Co. or this product.

    DISTRIBUTED BY THE KROGER CO., CINCINNATI, OH 45202

    QUESTIONS OR COMMENTS 1-800-632-6900 WWW.KROGER.COM

  • Principal Panel Display

    COMPARE TO

    CREST PRO-HEALTH GUM AND BREATH

    PURIFY CPC ANTIGINGIVITIS/ANTIPLAQUE

    ORAL RINSE SMOOTH MINT*

    Kroger

    Smooth Mint

    GUM DEFENSE

    ALCOHOL FREE MOUTHWASH

    ANTIGINGIVITIS/ANTIPLAQUE

    KILLS THE GERMS

    THAT CAUSE BAD BREATH

    CPC ANTIGINGIVITIS/ANTIPLAQUE ORAL RINSE

    HELPS DEFEND AGAINST EARLY SIGNS OF GUM DISEASE

    HELPS IMPROVE GUM HYGIENE

    SEALED WITH PRINTED NECKBAND

    FOR YOUR PROTECTION

    1 L (1 QT 1.8 FL OZ)

    33.8 FL OZ

    image description

  • INGREDIENTS AND APPEARANCE
    ANTIGINGIVITIS/ANTIPLAQUE 
    cetylpyridinium chloride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59450-997
    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)  
    zinc lactate (UNII: 2GXR25858Y)  
    benzoic acid (UNII: 8SKN0B0MIM)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    sucralose (UNII: 96K6UQ3ZD4)  
    sodium benzoate (UNII: OJ245FE5EU)  
    poloxamer 407 (UNII: TUF2IVW3M2)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59450-997-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/22/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35609/22/2022
    Labeler - The Kroger Co (006999528)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon790752542manufacture(59450-997)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture(59450-997)
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