Label: APLICARE HYDROGEN PEROXIDE- hydrogen peroxide liquid

  • NDC Code(s): 52380-0013-1
  • Packager: Aplicare Products, LLC
  • 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 February 12, 2018

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

  • Active Ingredient

    Hydrogen Peroxide USP 3%

    Purpose

    Antiseptic

  • Warnings

    For external use only.

    Ask a doctor before use if injuries are

    • deep or puncture wounds
    • serious burns

    Stop use and ask a doctor if

    • infection occurs
    • redness, irritation, swelling or pain persists or increases

    Keep out of reach of children. In case of accidental ingestions, seek professional assistance or consult a poison control center immediately.

  • QUESTIONS

    Questions or comments?1 800 760-3236 (Monday-Friday 8:30 AM-5:00 PM EST)

  • DOSAGE & ADMINISTRATION

    Apply locally as needed.

  • INACTIVE INGREDIENT

    • water
  • INDICATIONS & USAGE

    Topical anti-infective

  • PRINCIPAL DISPLAY PANEL

    Hydrogen Peroxide Packet

    Image of packet

  • INGREDIENTS AND APPEARANCE
    APLICARE HYDROGEN PEROXIDE 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-0013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE3 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52380-0013-130 mL in 1 PACKET; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/01/1983
    Labeler - Aplicare Products, LLC (081054904)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aplicare Products, LLC081068252manufacture(52380-0013)