Label: HYDROGEN PEROXIDE solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 1, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients

    Hydrogen Peroxide 3% USP

  • PURPOSE

    Purpose

    Antiseptic

  • WHEN USING

    Use

    Topical Anti-Infective

  • WARNINGS

    Warnings

    Ask a doctor before use if injures are

    Deep or puncture wounds

    Serious Burns

  • STOP USE

    Stop Use and Ask a doctor if

    infection occurs

    redness, irritation, swelling or pain persists or increase

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    In case of accidental ingestion, seek professional assistance or consult a Poison Control Center immediately

  • INDICATIONS & USAGE

    For External Use Only

    Directions

    Apply locally as needed

  • INFORMATION FOR PATIENTS

    Other Information

    Latex Free

  • INACTIVE INGREDIENT

    Inactive Ingredient

    purified water

  • PRINCIPAL DISPLAY PANEL



    Image of Pouch Label

    Pouch Label

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-8030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE0.03 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34645-8030-430 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33305/01/2010
    Labeler - Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. (530968767)
    Registrant - Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. (530968767)
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