Label: 3% HYDROGEN PEROXIDE- hydrogen peroxide liquid

  • 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 September 15, 2020

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  • Drug Facts

  • Active ingredient

    Hydrogen peroxide 3%

  • Purpose

    first aid antiseptic / oral debriding agent

  • INDICATIONS & USAGE

    Uses *????First aid to help prevent the risk of infection in minor cuts, scrapes, and burns. *Aids in the removal of phlegm, mucus, or other secretions associated with occasional sore mouth.

  • Warnings

    For external use only.

    Do not use *?in the eyes or apply over large areas of the body. *longer than one week.

    Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns.

    Stop use and ask a doctor if *swelling, rash, or fever develops. *the condition persists or gets worse. *sore mouth symptoms do not improve in 7 days. *irritation, pain or redness persists or worsens.

    Keep out of reach of children. If swallowed, get medical help or contact poison control center right away.

  • DOSAGE & ADMINISTRATION

    Directions? For use as a first aid antiseptic: *Clean affected area. *if bandaged, let dry first. *apply small amount of product on affected area 1-3 times a day. *may be covered with a sterile bandage. For use as an oral debriding agent (oral rinse): *adults and children 2 years of age and over: *mix with an equal amount of water. *swish around in the mouth over affected area for at least 1 minute and then spit out. Do not swallow. *use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor. *children under 12 years should be supervised in the use of this product. *children under 2 years of age: consult a dentist or doctor.

  • Other information

    *Keep tightly closed and in a dark place at room temperature.

    *Do not shake bottle. Hold away from face when opening.

  • INACTIVE INGREDIENT

    Inactive ingredient purified water

  • SPL UNCLASSIFIED SECTION

    Antiseptic

    * For treatment of minor cuts and abrasions.

    * Oral debriding agent.

    * Use as a gargle or rinse.

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

  • Packaging

    3% H2O2

  • INGREDIENTS AND APPEARANCE
    3% HYDROGEN PEROXIDE 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79590-001
    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:79590-001-00475 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/15/2020
    Labeler - MBS Medical Technologies, Inc. (117581535)
    Registrant - MBS Medical Technologies, Inc. (117581535)
    Establishment
    NameAddressID/FEIBusiness Operations
    MBS Medical Technologies Inc117581535manufacture(79590-001)