Label: DOP HYDROGEN PEROXIDE 3%- hydrogen peroxide liquid

  • NDC Code(s): 51048-040-08, 51048-040-16, 51048-040-32
  • Packager: Omega & Delta Co. Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 21, 2026

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Hydrogen peroxide 3% (stabilized)

  • 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 occasional sore mouth
  • Warnings

    for external use only.

  • Do not use

    • in the eyes or apply over large areas of the body
    • longer than 1 week
  • 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 right away

  • Directions

    First aid antiseptic:

    • clean the affected area
    • apply 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

    Oral debriding agent ( oral rinse):

    adults and children 2 years of age and over:

    • mix with an equal amount of water
    • swish around in the mouth over the affected area for at least 1 minute and then spit out
    • use up to 4 times daily after meals and at bedtime or as directed by a dentist or doctor
    • children under 12 years of age should be supervised in the use of this product
    • children under 2 years of age: consult a dentist or a doctor
  • Other Information

    Keep tightly closed and at a controlled room temperature.  Do not shake bottle.  Hold away from face when opening.

  • Inactive Ingredient

    Purified Water

  • SPL UNCLASSIFIED SECTION

    Distributed by:

    Omega & Delta Co., Inc.

    Carolina, P.R. 00984

  • Principal Display Panel

     DOP

      HYDROGEN

       PEROXIDE

     (AGUA OXIGENADA)

    3% Topical Solution U.S.P.

         First Aid Antiseptic

    • For Treatment of Minor Cuts and Abrasions
    • For Use as a Gargle or Rinse

    Do not use if safety seal is broken or missing.

    16 FL.OZ. (1PT)  473 mL

    DOP Hydrogen Peroxide

  • INGREDIENTS AND APPEARANCE
    DOP HYDROGEN PEROXIDE 3% 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51048-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51048-040-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2000
    2NDC:51048-040-08237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2006
    3NDC:51048-040-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00301/01/2000
    Labeler - Omega & Delta Co. Inc. (090317793)
    Establishment
    NameAddressID/FEIBusiness Operations
    Omega & Delta Co. Inc.090317793manufacture(51048-040)