Label: HYDROGEN PEROXIDE solution

  • 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 17, 2020

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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 one week
  • Ask a doctor before use if you have

    deep or pucture 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 the 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 sprayer tip away from face when opening.

  • Inactive ingredients

    purified water

  • adverse reactions

    Manufactured for Big Lots

    By:Vi-Jon, Inc

    8515 Page Avenue

    St. Louis, MO 63114

    V#425040 Item 100051394

  • principal display panel

    SOUNDBODY

    First Aid Antiseptic

    HYDROGEN

    PEROXIDE

    Topical Solution

    3% USP

    First Aid Antiseptic

    For treatment of minor cuts and abrasions

    8 FL OZ (236 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11344-002-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/08/2014
    2NDC:11344-002-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/08/2014
    3NDC:11344-002-34236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/08/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/08/2014
    Labeler - Sound Body (150931459)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture(11344-002)