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 April 18, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Hydrogen Peroxide topical solution U.S.P. 3%

  • Purpose

    First Aid Antiseptic

  • Uses

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

  • Warnings For external use only

    Do not use

    • in eyes or apply over large areas of the body
    • longer than one 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 consult doctor if

    • the condition persists or gets worse

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

  • Directions

    • clean the affected area
    • spray a small amount of this product on the area 1 to 3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first
  • Other information

    • store at room temperature
  • Inactive ingredients

    purified water

  • Questions or Comments?

    1-877-973-2811

  • PRINCIPAL DISPLAY PANEL – 2 oz. bottle label

    HYDROGEN
    PEROXIDE

    First Aid Antiseptic
    Irrigates & Cleanses
    Wounds

    Convenient pump
    spray allows no-touch
    application. Use as a
    first aid treatment for
    minor cuts, scrapes
    and abrasions

    2 fl. oz. (59.1 mL)

    Xpect
    First Aid

    PRINCIPAL DISPLAY PANEL – 2 oz. bottle label
  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68421-5400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    hydrogen peroxide (UNII: BBX060AN9V) (hydrogen peroxide - UNII:BBX060AN9V) hydrogen peroxide43.275 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68421-5400-00.0591 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/18/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/18/2013
    Labeler - Cintas First Aid & Safety (056481716)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(68421-5400)
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