Label: HYDROGEN PEROXIDE solution

  • NDC Code(s): 53942-871-43, 53942-871-45
  • Packager: Demoulas Super Markets, Inc
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 19, 2024

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  • Active ingredient

    Hydrogen peroxide (stabilized) 3%

    Purpose

    First aid antiseptic
    Oral debriding agent

  • Use

    • first aid to help prevent the rise 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 then 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 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 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 DEMOULAS SUPER MARKETS, INC.
    875 East Street, Tewksbury, MA 01876

  • principal display panel

    "MORE FOR YOUR DOLLAR"

    Market Basket

    HYDROGEN PEROXIDE

    TOPICAL SOLUTION USP

    FIRST AID ANTISEPTIC

    ORAL DEBRIDING AGENT

    Square bottle uses less plastic than a similarly sized round bottle

    Recyclable (if available in your area)

    Do not use if printed seal under cap is broken or missing

    16 FL OZ (1PT) 473 mL

    image description

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53942-871
    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:53942-871-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1989
    2NDC:53942-871-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/15/1989
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00307/15/1989
    Labeler - Demoulas Super Markets, Inc (007869647)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(53942-871)