Label: HYDROGEN PEROXIDE solution

  • NDC Code(s): 55316-871-43, 55316-871-45
  • Packager: DZA Brands,
  • 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 March 24, 2022

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  • Active ingredient

    Hydrogen peroxide (stabilized) 3%

    Purpose

    First aid antiseptic

  • Use

    • first aid to help prevent the risk of infection in minor cuts, scrapes and burns

  • Warnings

    For external use only

    Do not use

    •in the eyes or apply over large areas of the body • longer than 1 week

    As a doctor before use if you have

    deep or puncture wounds, animal bites or serious burns

    Stop use and ask a doctor if

    • the condition persists or gets worse 

    Keep out of reach of children.

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

  • Directions

    •clean the affected area
    •apply a small amount of product on the affected area 1 to 3 times a day
    •may be covered with a sterile bandage
    •if bandaged, let dry first

  • Other information

    keep tightly closed and at controlled room temperature.  Do not shake bottle.  Hold away from face when opening.

  • Inactive ingredient

    purified water

  • SPL UNCLASSIFIED SECTION

    Distributed by: DZB Brands, LLC
    2110 Executive Drive
    Salisbury, NC 28147

    For product questions or concerns contact us at 1-866-322-2439. Please include UPC number and code from package.

  • principal display panel

    healthy accents

    Hydrogen Peroxide Topical Solution USP

    •  for minor cuts & abrasions

    Sealed with printed neckband for your protection

    16 FL OZ (1 PT) 473 mL

    image description

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-871
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE.3 kg  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55316-871-43.473 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/22/2009
    2NDC:55316-871-45.946 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/22/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/22/2009
    Labeler - DZA Brands, (090322194)
    Registrant - Vi Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC790752542manufacture(55316-871)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi Jon, LLC088520668manufacture(55316-871)
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