Label: HYDROGEN PEROXIDE solution

  • NDC Code(s): 33992-0871-4, 33992-0871-8
  • Packager: Greenbrier International, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 21, 2024

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

  • Active ingredient

    Hydrogen peroxide (stablized) 3%

  • Purpose

    First Aid Antiseptic

    Oral debriding agent

  • Uses

    • first aid to help prevent the risk of infection in minor cuts, scrapes and burns
    • aids in the removal of phlegm, mucus, or other secretions assoicated with occasional sore mouth.

  • Warnings

    For external use only

  • Do not use

    • in the eyes or apply over large areas of the 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

    First aid antiseptic:

    • 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

    Oral Debriding agent (oral rinse): adults and children 2 years of ago or over:

    • mix with an equal amount of water
    • swish around in the mouth over the affected area for at least 1 minute and then spit out
    • use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor
    • children under 12 years of age should be supervised in the use of this product
    • children under 2 years of age: consult a dentist or doctor
  • 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

    DISTRIBUTED BY

    Greenbrier International, Inc

    500 Volvo Parkway

    Chesapeake, VA 23320

  • Principal display panel

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

    ASSURED

    Hydrogen

    Peroxide

    TOPICAL SOLUTION USP

    FIRST AID ANTISEPTIC

    ORAL DEBRIDING AGENT

    Square bottle uses less plastic then a similarly sized round bottle

    Recyclable (if available in your area)

    32 FL OZ (1QT) 946 mL

    mm01

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0871
    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:33992-0871-4946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/12/2009
    2NDC:33992-0871-8177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/12/200903/20/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00305/12/2009
    Labeler - Greenbrier International, Inc (610322518)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091520manufacture(33992-0871)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(33992-0871)