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 June 21, 2016

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  • ACTIVE INGREDIENTS

    Hydrogen Peroxide 3.0%

  • PURPOSE

    Topical Antiseptic

  • USES

    • treatment of minor cuts and abrasions
    • helps prevent infection
  • Warnings

    For external use only

    Do not use

    • in eyes or near mucous membranes
    • for serious burns
    • for a prolonged period of time
    • in case of deep puncture wounds

    Stop use and ask a doctor if

    • rash or infection occurs
    • irritation, redness, or swelling increases

    Keep out of reach of children.

    If swallowed get medical help or contact a Poison Control Center right away

  • Directions

    • hold 4-6 inches from surface
    • spray area until wet
  • Other Information

    • product should be stored in a cool, dry place
  • Inactive Ingredients

    Water

  • Label

    Label

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44224-3122
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE3.57 mL  in 118 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44224-3122-1118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/19/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35608/19/2014
    Labeler - Tender Corporation (064437304)
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