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

    Intended for use as a general purpose topical disinfectant for first aid treatment of minor cuts and abrasion. Also suitable for use as a mouth wash.

  • ACTIVE INGREDIENT

    Active ingredient: hydrogen peroxide, 3% w/v

  • KEEP OUT OF REACH OF CHILDREN

    For external use only.Do not use in the eyes or over large areas of the body. Keep out of the reach of children.Stop use and get medical help if condition persists or worsens.

  • INDICATIONS & USAGE

    Intended for use as a general purpose topical disinfectant for first aid treatment of minor cuts and abrasion. Also suitable for use as a mouth wash.

  • WARNINGS

    For external use only. Do not use in the eyes or over large areas of the body. Keep out of the reachof children.Stop use and get medical help if condition persists or worsens.

  • 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

    Purified Water.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12745-205
    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:12745-205-013785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/16/2020
    Labeler - Medical Chemical Corporation (008496861)
    Registrant - Medical Chemical Corporation (008496861)
    Establishment
    NameAddressID/FEIBusiness Operations
    Medical Chemical Corporation008496861manufacture(12745-205)
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