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 February 14, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Hydrogen Peroxide Topical Solution 3%

  • 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

    • in the 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
    • serious burns

    Stop use and ask a doctor if conditions persist or get 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 - 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?

    1-866-651-3660

    Mon-Fri 8:00am-5:00pm EST

    Manufactured for American Safety & First Aid Osceola, IN 46561

    V1_11-7-19

  • Principal Display Panel – Bottle Label

    0661

    NDC 73598-0661-1

    Hydrogen
    Peroxide

    First Aid Antiseptic

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

    American Safety
    & First Aid

    2 fl. oz. (59.1 ml)

    Principal Display Panel – Bottle Label
  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73598-0661
    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:73598-0661-159.1 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/14/2020
    Labeler - JHK Inc (867236309)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(73598-0661)
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