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 September 14, 2020

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

  • DOSAGE & ADMINISTRATION

    3.78L NDC: 77610-202-01

    Dosage

  • WARNINGS

    3.78L NDC: 77610-202-01

    Warning Section

  • INACTIVE INGREDIENT

    3.78L NDC: 77610-202-01

    Inactive Ingredient section

  • INDICATIONS & USAGE

    3.78L NDC: 77610-202-01 indication and usage section

  • KEEP OUT OF REACH OF CHILDREN

    3.78L NDC: 77610-202-01 keep it out of reach of children

  • PURPOSE

    3.78L NDC: 77610-202-01 Purpose section

  • ACTIVE INGREDIENT

    3.78L NDC: 77610-202-01

    Active Ingredient section

  • PRINCIPAL DISPLAY PANEL

    3.78 L NDC: 77610-202-01

    3.78L Label

    473 mL NDC: 77610-202-16

    473 mL NDC: 77610-202-16

    946 mL NDC: 77610-202-32

    946 mL NDC: 77610-202-32

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77610-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE0.03 L  in 0.03 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77610-202-011 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/13/2020
    2NDC:77610-202-160.473 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/13/2020
    3NDC:77610-202-320.946 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/13/2020
    Labeler - ImKor Limited Liability Company (094772617)
    Establishment
    NameAddressID/FEIBusiness Operations
    ImKor Limited Liability Company094772617manufacture(77610-202)