Label: CLOSYS SILVER HEALTHY GUMS- cetylpyridinium chloride liquid

  • NDC Code(s): 58578-0407-1
  • Packager: Rowpar Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 26, 2023

If you are a consumer or patient please visit this version.

  • Active ingredient

    Active ingredientPurpose
    Cetylpyridinium chloride 0.075Antigingivitis/Antiplaque
  • PURPOSE

  • 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 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

    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.

  • DOSAGE & ADMINISTRATION

    Directions
    Adults and children
    12 years and over
    Vigorously swish 20 milliliters of rinse
    between your teeth for 30 seconds and
    then spit out. Do not swallow rinse.
    Children 6 years to
    under 12 years
    Supervise use.
    Children under
    6 years
    Do not use.
  • Other Information

    • Do not use if safety seal is broken or missing.
    • This rinse is not intended to replace brushing or flossing
  • INACTIVE INGREDIENT

    Inactive ingredients water, potassium sorbate, trisodium phosphate, citric acid, sodium benzoate, mint flavor, sucralose, benzoic acid

  • Questions or comments?

    call 1-800-643-3337

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Non-Burning, Non-Irritating Formula

    A CLEANER MOUTH
    A HEALTHIER YOU®

    ClōSYS®
    Antigingivitis/Antiplaque Mouth Rinse

    HEALTHY
    GUMS


    SENSITIVE
    MOUTH RINSE


    KILLS GERMS
    THAT CAUSE GINGIVITIS, PLAQUE
    & BAD BREATH

    Helps Reverse Early Signs
    of Gum Disease

    Freshens Breath

    Non Burning, Alcohol Free

    Gentle Mint

    32 fl oz (946 mL)

    Our Story

    Founder of CloSYS® & Periodontist Dr. Perry Ratcliff
    had a bold belief that there had to be a better/gentler
    way to help with oral care. Dr. Ratcliff didn’t agree
    with the common myth ‘If it hurts, it must be good
    for you.’

    CloSYS® took a different approach―keep it gentle,
    yet effective, and people will use it long enough
    to make a difference in their oral health. After
    discovering that his first patented formula was not
    only extremely gentle but incredibly effective, he
    gathered a small group of dental professionals and
    business leaders to start their journey toward what
    is today Founder of CloSYS® Oral Care.

    What Makes CloSYS®
    Products Different?

    Simply put, CloSYS® is the Gentlest, Oral Care. Ever.®
    All CloSYS® formulas are highly effective and
    extremely gentle so they are not harsh or irritating to
    sensitive mouths. And because it’s so gentle, it
    means you can swish it in your mouth longer without
    having to spit it out early and risk not getting the full
    benefit of the rinse.

    CloSYS® products are free of alcohol, sulfates,
    triclosan, and other harsh ingredients that can
    burn or irritate sensitive mouths.

    How Does CloSYS®
    Healthy Gums Work?

    CloSYS® Healthy Gums Oral Rinse kills germs that
    cause gingivitis, plaque and bad breath and helps
    reverse early signs of gum disease (redness,
    bleeding and inflammation).

    Its gentle formula protects against plaque formation
    that oftens leads to gingivitis, while the gentle mint
    flavor freshens breath. And, the formula doesn’t
    contain alcohol, sulfates, triclosan, and other
    ingredients that can burn or irritate the mouth or
    gums so you can rinse longer and get great results!

    HEALTHY Mouth= HEALTHY Body
    Gentlest.
    Oral Care.
    Ever.®

    Distributed by:
    Rowpar Pharmaceuticals, Inc.
    Bridgewater, NJ 08807
    1(800) 643-3337 closys.com

    This bottle is recyclable. Please
    support recycling in your community.

    55002-44

    Carton

    A CLEANER MOUTH
    A HEALTHIER YOU®

    ClōSYS
    Antigingivitis/Antiplaque Mouth Rinse

    HEALTHY
    GUMS


    SENSITIVE
    MOUTH RINSE


    KILLS GERMS
    THAT CAUSE GINGIVITIS, PLAQUE
    & BAD BREATH

    Helps Reverse Early Signs
    of Gum Disease

    Freshens Breath

    Non Burning, Alcohol Free

    Gentle Mint

    32 fl oz (946 mL)

    52532-85

    Distributed by: Rowpar Pharmaceuticals, Inc.
    Bridgewater, NJ 08807
    1(800) 643-3337 closys.com

    This bottle is recyclable. Please
    support recycling in your community.

    52532-86


    Label
  • INGREDIENTS AND APPEARANCE
    CLOSYS SILVER HEALTHY GUMS 
    cetylpyridinium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58578-0407
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Cetylpyridinium Chloride (UNII: D9OM4SK49P) (Cetylpyridinium - UNII:CUB7JI0JV3) Cetylpyridinium Chloride0.75 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Sodium Phosphate, Tribasic, Dodecahydrate (UNII: B70850QPHR)  
    Anhydrous Citric Acid (UNII: XF417D3PSL)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Mint (UNII: FV98Z8GITP)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58578-0407-11 in 1 CARTON03/15/2023
    1946 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02203/15/2023
    Labeler - Rowpar Pharmaceuticals, Inc. (783704661)