Label: HYDROGEN PEROXIDE spray

  • NDC Code(s): 61010-5400-2, 61010-5400-4
  • Packager: Safetec of America, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 7, 2024

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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

    • near eyes or mucous membranes
    • on deep or puncture wounds, animal bites, or serious burns

    Keep out of reach of children.

    Caution

    • not for use on large areas of the body
    • if redness, irritation, swelling or pain persists or increases, discontinue use and consult a physician
  • Directions

    • spray over affected area
    • if bandaged, let dry first
  • Inactive ingredients

    purified water

  • PRINCIPAL DISPLAY PANEL – 2 oz. bottle label

    NDC 61010-5400-2

    Safetec

    Hydrogen
    Peroxide Spray

    First Aid to Help
    Prevent Infection in
    Minor Cuts, Scrapes
    and Burns.

    2 fl. oz. (59.1ml)
    Reorder no. 53001

    PRINCIPAL DISPLAY PANEL – 2 oz. bottle label
  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:61010-5400-259.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/16/2012
    2NDC:61010-5400-4118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/16/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00302/16/2012
    Labeler - Safetec of America, Inc. (874965262)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262manufacture(61010-5400)
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