Label: FIRST AID ONLY HYDROGEN PEROXIDE 3%- hydrogen peroxide spray

  • 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 January 9, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Hydrogen Peroxide 3.0%

  • Purpose

    First Aid Antiseptic

  • Uses

    First aid to help prevent infection in minor cuts, scrapes and burns.

  • Warnings

    For external use only.

    Do not use

    Do not use

    • in the eyes
    • over large areas of the body
    • longer than 1 week unless directed by a doctor

    Ask a doctor before use if you have a deep puncture wound, animal bite, or serious burn

    Stop use and ask a doctor if condition persists or gets worse

    Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • spray a small amount over cleaned affected area 1 to 3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first
  • Inactive ingredients

    purified water

  • QUESTIONS

    Questions? 1.800.835.2263

  • PRINCIPAL DISPLAY PANEL

    Bottle Label Bottle Label

  • INGREDIENTS AND APPEARANCE
    FIRST AID ONLY HYDROGEN PEROXIDE 3% 
    hydrogen peroxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0935(NDC:61010-5400)
    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:0924-0935-0159.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/16/2023
    2NDC:0924-0935-02118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/16/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/16/2023
    Labeler - Acme United Corporationn (001180207)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation045924339relabel(0924-0935) , repack(0924-0935)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acme United Corporation080119599relabel(0924-0935) , repack(0924-0935)
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