Label: HYDROGEN PEROXIDE solution

  • NDC Code(s): 68599-2301-2, 68599-2301-6, 68599-2301-9
  • Packager: McKesson Medical-Surgical Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 12, 2023

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  • SPL UNCLASSIFIED SECTION

    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, mucous, 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 a small amount of product on the area 1 to 3 times daily
    • 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 doctor
  • Other Information

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

  • Inactive Ingredient

    purified water

  • SPL UNCLASSIFIED SECTION

    Distributed By McKesson Medical-Surgical Inc.
    Richmond, VA 23228

  • PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

    NDC 68599-2301-6

    McKESSON

    Hydrogen

    Peroxide 3%

    TOPICAL SOLUTION USP
    FIRST AID ANTISEPTIC
    ORAL DEBRIDING AGENT

    For treatment of minor cuts and abrasions.
    For use as a gargle or rinse. Tamper evident cap
    for your protection. If ring-band is detached from
    cap or missing, do not use.

    16FL OZ (1 pt)
    (473 mL)

    MFR # 23-D0012

    Distributed By McKesson Medical-Surgical Inc.

    Richmond, VA 23233

    LU-5750-1112 1-07-D0012R10

    Made in USA 23-D0012 each

  • PRINCIPAL DISPLAY PANEL - 473 mL Drug facts panel

    Drug Facts

    23-D0012

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-2301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-2301-2118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/09/2013
    2NDC:68599-2301-6473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/09/2013
    3NDC:68599-2301-93785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/09/201309/02/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00310/09/2013
    Labeler - McKesson Medical-Surgical Inc. (023904428)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hydrox Laboratories025164302manufacture(68599-2301)
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