Label: CLOSYS- hydrogen peroxide rinse

  • NDC Code(s): 58578-0613-1
  • Packager: Rowpar Pharmaceuticals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 15, 2025

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

  • Drug Facts

  • Active ingredient

    Hydrogen Peroxide 1.5% (w/v)

  • Purpose

    Oral debriding agent
    Oral wound cleanser

  • Uses

    • For temporary use to cleanse canker sores and minor wounds or minor gum inflammation resulting from dental procedures, dentures, orthodontic appliances, accidental injury, or other irritations of the mouth and gums.
    • Assist in the removal of foreign material from minor oral wounds.
  • Warnings

  • KEEP OUT OF REACH OF CHILDREN

    Do not use this product for more than 7 days unless directed by a dentist, or physician.

    When using this product, do not swallow.

    Stop use and ask a doctor if

    • sore mouth symptoms do not improve within 7 days.
    • irritation, pain or redness persists or worsens.
    • swelling, rash or fever develops.

    Keep out of reach of children. 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 older

    • Use 10 mL (two teaspoons) around in the mouth over affected areas for at least 1 minute and spit out
    • Use up to 4 times daily after meals and at bedtime or as directed by a dentist or physician

    Children 6 years to under 12 years of age: supervise use

    Children under 6 years of age: do not use

  • Other Information

    • Do not use if safety seal is broken or missing
    • Cap tightly
    • Keep away from direct sunlight
    • Store at room temperature, 68 to 77°F (20 to 25°C)
  • Inactive ingredients

    water, polypropylene glycol, flavors, polysorbate 20, polysorbate 80, sucralose, disodium EDTA, menthol, citric acid

  • Questions or comments?

    call 1-800-643-3337

  • QUESTIONS

  • SPL UNCLASSIFIED SECTION

  • Packaging

    A CLEANER MOUTH
    A HEALTHIER YOU®

    CLoSYS®
    Oral Debriding Agent

    MOUTH
    SORES


    SENSITIVE
    MOUTH RINSE

    PROMOTES HEALING

    HELPS CLEANSE & PROMOTE HEALING OF
    ORAL SORES, MOUTH BURNS & IRRITATION

    For Canker Sores, Cheek Bites,
    Irritation from Dentures or Braces,
    Gum Irritation

    Non Burning, Alcohol-Free
    Formula

    Gentle Mint

    16 fl oz (473mL)

    52516-75

    Front Label

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

    52516-76

    Back Label
  • INGREDIENTS AND APPEARANCE
    CLOSYS 
    hydrogen peroxide rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58578-0613
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hydrogen Peroxide (UNII: BBX060AN9V) (Hydrogen Peroxide - UNII:BBX060AN9V) Hydrogen Peroxide1.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Sucralose (UNII: 96K6UQ3ZD4)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Menthol, Unspecified Form (UNII: L7T10EIP3A)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPEPPERMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58578-0613-1473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/27/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02201/27/2025
    Labeler - Rowpar Pharmaceuticals, Inc. (783704661)