Label: 3% HYDROGEN PEROXIDE- hydrogen peroxide solution

  • NDC Code(s): 52000-433-16, 52000-433-32
  • Packager: Universal Distribution Center LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2025

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

  • Drug Facts

  • Active ingredient

    Hydrogen peroxide (stabilized) 3%

  • Purpose

    First aid antiseptic / oral debriding agent

  • Uses

    • first aid to help prevent the risk of infection in minor cuts, scrapes, and burns • aids in the removal of phlegm, mucus, or other secretions associated with an occasional sore mouth

  • Warnings

    For external use only.

    When using this product • do not get into eyes • do not apply over large areas of the body • do not use longer than one week unless directed by a doctor

    Ask a doctor before use if you have
    • deep or puncture wounds, animal bites, or serious burns

    Stop use and ask a doctor if • the condition persists or gets worse • sore mouth symptoms do not improve in 7 days • irritation, pain, or redness persists or worsens • swelling, rash, or fever develops

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    First aid antiseptic:
    • clean the affected area • apply a small amount of product on the affected area 1 to 3 times a day • may be covered with a sterile bandage • if bandaged, let dry first

    For use as an oral debriding agent (oral rinse)
    • adults and children over 2 years of age:
      • mix with an equal amount of water
      • swish around in the mouth over affected area for at least 1 minute and then spit out. Do not swallow
      • use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor
    • children under 12 years should be supervised in the use of this product
    • children under 2 years of age: consult a dentist or doctor

  • Other information

    • keep tightly closed and store at controlled room temperature.
    • do not shake the bottle. Hold away from face when opening.

  • Inactive ingredient

    purified Water

  • SPL UNCLASSIFIED SECTION

    For the Treatment of Minor Cuts and Abrasions

    For Use as a Gargle or Rinse

    TAMPER EVIDENT: DO NOT USE IF THE PRINTED SAFETY SEAL AROUND OR UNDER THE CAP IS BROKEN OR MISSING.

    Mfd for and Distributed by:
    Universal Distribution Center LLC
    330 Applegarth Road, Monroe Township,
    NJ 08831

    www.universaldc.com

    “U” is a Registered Trademark of
    Universal Distribution Center, LLC

    Made in Turkey

  • Packaging

    Hydrogenperoxide

  • INGREDIENTS AND APPEARANCE
    3% HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-433
    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:52000-433-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/08/2025
    2NDC:52000-433-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/08/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00312/08/2025
    Labeler - Universal Distribution Center LLC (019180459)