HYDROGEN PEROXIDE SOLUTION [LIBERTY PROCUREMENT, INC.]

HYDROGEN PEROXIDE SOLUTION [LIBERTY PROCUREMENT, INC.]
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NDC 63940-871-17, 63940-871-34, 63940-871-43, 63940-871-45, 63940-871-99
Set ID c2bdecb6-6da6-4bed-9893-faa912f00b1d
Category HUMAN OTC DRUG LABEL
Packager Liberty Procurement, Inc.
Generic Name
Product Class
Product Number
Application Number PART333A
  • Active ingredient

    Hydrogen peroxide (stabilized) 3%

  • Purpose

    First Aid Antiseptic

    Oral debriding agent

  • Use

    • 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 occsional 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 pucture 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 redess 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 coverd with a sterile bandage
    • if bandaged, let dry first

    Oral debriding agent: adults, children over 2 years of age:

    • mix with an equal amount of water
    • swish around in the mouth over the affected area for at least 1 minure, then spit out
    • use up to 4 times daily after meals and at bedtime
    • children under 12 years of age should be supervised in the use
    • children under 2 years of age: consult a dentist, 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 bny Liberty Procurement, Inc.

    650 Liberty Ave., Union, NJ 07083 USA

  • principal display panel

    COREVALUES

    Hydrogen Peroxide

    TOPICAL SOLUTION USP

    • First aid antiseptc For treatments of minor cuts & abrasions
    • Oral debriding agent - for use as a gargle or rinse

    DO NOT USE IF PRINTED SEAL INDER CAP IS BROKEN OR MISSING

    16 fl oz (1 PT) 473 mL

    image description

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-871
    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:63940-871-34236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/12/2009
    2NDC:63940-871-17473 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/12/2009
    3NDC:63940-871-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/12/2009
    4NDC:63940-871-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/12/2009
    5NDC:63940-871-99237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/12/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/12/2009
    Labeler - Liberty Procurement, Inc. (804085293)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(63940-871)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(63940-871)

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