Label: HYDROGEN PEROXIDE ANTISEPTIC- 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 October 6, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    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

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

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

    Stop use and ask a doctor

    • in case of deep puncture wounds, animal bites, or serious bums
    • if condition persists or gets worse
  • Directions

    • spray a small amount over cleaned affected area 1 to 3 times daily
    • if bandaged, let dry first
  • Inactive ingredient

    purified water

  • Principal Display Panel - Bottle Label

    13-090

    ANTISEPTICS

    FIRST AID ONLY®

    Hydrogen Peroxide
    Antiseptic Spray

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

    4 fl oz (118.3 ml)

    Principal Display Panel - Bottle Label
  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE ANTISEPTIC 
    hydrogen peroxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-0932
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hydrogen Peroxide (UNII: BBX060AN9V) (Hydrogen Peroxide - UNII:BBX060AN9V) Hydrogen Peroxide30 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0924-0932-010.1183 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/06/2014
    Labeler - Acme United Corp (001180207)
    Registrant - Safetec of America, Inc (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc874965262MANUFACTURE(0924-0932)
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