Label: HYDROGEN PEROXIDE solution

  • NDC Code(s): 65055-501-01, 65055-501-02, 65055-501-03
  • Packager: Laboratorios Jaloma, S.A. de C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 9, 2023

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  • Drug Facts

  • Active Ingredient

    Hydrogen peroxide topical solution 3%

    Purpose

    First aid antiseptic

  • Use

    First aid to help prevent 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 unless directed by a doctor.

    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

    Keep out of the 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 this product on the area 1 to 3 times daily

    • May be covered with a sterile bandage

    • Let the product dry

  • Other Information

    Store the bottle tightly closed and away from heat.

  • Inactive ingredients

    Acetanilide, ethyl alcohol, water.

  • Questions or Comments?

    800 9811 542

  • Package Labeling:224ml

    Label

  • Package Labeling:448ml

    Label2

  • Package Labeling:1L

    Label3

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65055-501
    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
    ACETANILIDE (UNII: SP86R356CC)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65055-501-01224 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/18/2013
    2NDC:65055-501-02448 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/18/2013
    3NDC:65055-501-031 in 1 BOX02/26/2022
    31000 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00309/18/2013
    Labeler - Laboratorios Jaloma, S.A. de C.V. (811122357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratorios Jaloma, S.A. de C.V.811122357manufacture(65055-501)
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