Label: HELLO PEACE OUT PLAQUE PEACE OUT, PLAQUE ANTIGINGIVITIS- cetylpyridinium chloride mouthwash

  • NDC Code(s): 35000-683-10
  • Packager: Colgate-Palmolive 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 August 7, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Cetylpyridinium chloride 0.075%

  • Purpose

    Antigingivitis/Antiplaque

  • Uses

    • helps prevent and reduce plaque and gingivitis
    • helps control plaque bacteria that contribute to the development of gingivitis, an early form of gum disease, and bleeding gums
  • Warnings

    Stop use and ask a dentist if

    • gingivitis, bleeding, or redness persist for more than two 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 swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 12 years of age and oldervigorously swish 20 mL of rinse between your teeth twice day for 30 seconds, then spit out. Do not swallow the rinse.
    children 6 years to under 12 years of agesupervise use
    children under 6 years of agedo not use
  • Other information

    • this rinse is not intended to replace brushing or flossing.
  • Inactive ingredients

    water, glycerin, aloe barbadensis leaf, polysorbate 80, xylitol, erythritol, poloxamer 407, flavor, sodium benzoate, cocos nucifera (coconut) oil1, citric acid, melaleuca alternifolia (tea tree) leaf oil1, rebaudioside a1.

    1
    certified organic
  • Questions?

    1-855-444-3556

  • SPL UNCLASSIFIED SECTION

    Dist. by Hello Products
    LLC Montclair, NJ 07042

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    naturally
    friendly™
    hello®

    peace out, plaque

    antigingivitis/antiplaque mouthwash

    natural mint
    with aloe vera + coconut oil

    promotes healthy gums.
    freshens like crazy.
    no alcohol, no brainer.

    16 FL OZ (473 mL)

    PS0038424
    45052

    PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    HELLO PEACE OUT PLAQUE   PEACE OUT, PLAQUE ANTIGINGIVITIS
    cetylpyridinium chloride mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-683
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE15 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XYLITOL (UNII: VCQ006KQ1E)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35000-683-10473 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35607/01/2023
    Labeler - Colgate-Palmolive Company (001344381)
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