Label: FIRST AID ONLY HYDROGEN PEROXIDE - 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 February 23, 2016

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

    Close
  • Active ingredient

    Hydrogen Peroxide 3.0%

    Close
  • Purpose

    First Aid Antiseptic

    Close
  • Uses

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

    Close
  • 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 burns
    • if condition persists or gets worse
    Close
  • Directions

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

    purified water

    Close
  • Principal Display Panel - Bottle Label

    FIRST AID ONLY®

    M5124

    ANTISEPTICS

    Hydrogen Peroxide
    Antiseptic Spray

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

    4 fl oz (118.3ml)

    NDC 0924-0171-04

    Principal Display Panel - Bottle Label
    Close
  • INGREDIENTS AND APPEARANCE
    FIRST AID ONLY HYDROGEN PEROXIDE  
    hydrogen peroxide spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-0171
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Hydrogen Peroxide (UNII: BBX060AN9V) (Hydrogen Peroxide - UNII:BBX060AN9V) Hydrogen Peroxide 30 mL  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0924-0171-04 0.1183 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 11/26/2014
    Labeler - Acme United Corp. (001180207)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    Name Address ID/FEI Business Operations
    Safetec of America, Inc. 874965262 MANUFACTURE(0924-0171)
    Close