Label: 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 January 17, 2022

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  • PURPOSE

    Usage: Intended for use as a general purpose topical antiseptic for first-aid treatment of minor cuts and abrasions.  In case of deep or puncture wounds consult a physician.  Discontinue use and get medical attention if redness, irritation or infection develops.

  • ACTIVE INGREDIENT

    Active ingredient: hydrogen peroxide, 3% w/v in water.

  • KEEP OUT OF REACH OF CHILDREN

    For External Use Only.  Do not use in eyes or over large areas of the body.  Keep out of the reach of children.

  • INDICATIONS & USAGE

    Usage: Intended for use as a general purpose topical antiseptic for first-aid treatment of minor cuts and abrasions.  In case of deep or puncture wounds consult a physician.  Discontinue use and get medical attention if redness, irritation or infection develops.

  • WARNINGS

    For External Use Only.  Do not use in eyes or over large areas of the body.  Keep out of the reach of children.

  • DOSAGE & ADMINISTRATION

    For oral hygiene, dilute with an equal volume of water and gargle for about one minute.  Rinse with water.  In case of accidental ingestion contact a physician or a poison control center.

  • INACTIVE INGREDIENT

    Active ingredient: hydrogen peroxide, 3% w/v in water.

  • PRINCIPAL DISPLAY PANEL

    h2o2label.jpg

    Hydrogen Peroxide Label

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12745-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE8.57 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:12745-202-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/21/1980
    2NDC:12745-202-02118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/21/1980
    3NDC:12745-202-033785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/21/1980
    4NDC:12745-202-04208175 mL in 1 DRUM; Type 0: Not a Combination Product07/21/1980
    5NDC:12745-202-05946250 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product07/21/1980
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/21/1980
    Labeler - Medical Chemical Corporation (008496861)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medical Chemical Corporation008496861manufacture(12745-202)
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