Label: 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 November 11, 2013

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  • 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 fl. oz Bottle Label

    The Provision
    First Aid
    Line™

    Hydrogen
    Peroxide Spray

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

    2 fl. oz. (59.1 ml)

    Reorder no. 3503

    Principal Display Panel – 2 fl. oz Bottle Label
  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-5400
    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:69103-5400-00.0591 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/25/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/25/2022
    Labeler - Provision Medical (036936831)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(69103-5400)
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