Label: HYDROGEN PEROXIDE solution

  • NDC Code(s): 0869-0871-18, 0869-0871-43, 0869-0871-45, 0869-0871-72, view more
    0869-0871-82, 0869-0871-99
  • Packager: Vi-Jon, LLC
  • 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 29, 2023

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  • Active ingredient

    Hydrogen peroxide (stabilized) 3%

  • Purpose

    First Aid Antiseptic

  • Uses

    • 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 puncture wounds, animal bites or serious burns

  • Stop use and ask a doctor if

    • the condition persists or gets worse
    • sore mouth symptoms do not improve in 7 days
    • irritation, pain or redness persists or worsens
    • swelling, rash, or fever develops
  • Keep out of reach of children.

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

  • Directions

    For First aid antiseptic:

    • clean the affected area
    • spray 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: Vi-Jon, LLC.,

    8515 Page Ave.

    St. Louis, MO 63114

  • Principal Display Panel

    Swan

    Hydrogen Peroxide

    Topical Solution USP

    • First Aid Antiseptic/Oral Debriding Agent
    • For treatment of minor cuts & abrasions

    6 FL OZ (177 mL) 

    image description

  • Principal Display Panel

    Do not use if printed seal under cap is broken or missing

    mountain falls

    for treatment of minor cuts and abrasions

    3% U.S.P.

    hydrogen peroxide topical solution USP

    first aid antiseptic

    oral debriding agent

    Made in the USA with US and foreign parts

    32 FL OZ (1 QT) 946 mL

    image description

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0869-0871
    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:0869-0871-72295 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/09/2017
    2NDC:0869-0871-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/09/2017
    3NDC:0869-0871-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/09/2017
    4NDC:0869-0871-18118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/09/2017
    5NDC:0869-0871-99237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/09/2017
    6NDC:0869-0871-82177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/09/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/09/2017
    Labeler - Vi-Jon, LLC (790752542)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(0869-0871)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(0869-0871)
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