HYDROGEN PEROXIDE SOLUTION [ARMY + AIR FORCE EXCHANGE SERVICE]

HYDROGEN PEROXIDE SOLUTION [ARMY + AIR FORCE EXCHANGE SERVICE]
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NDC 55301-871-43, 55301-871-45
Set ID a71734c6-6b92-4d3d-84d1-a07f592fa828
Category HUMAN OTC DRUG LABEL
Packager Army + Air Force Exchange Service
Generic Name
Product Class
Product Number
Application Number PART333A
  • 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 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

    As 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: adults and children 2 years of age and over:
    • mix with 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

    Manufactured for your Military Exchanges
    By Vi-Jon, LLC 8515 Page Ave,

    St. Louis, MO 63114

  • principal display panel

    exchange select
    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)
    SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
    32 FL OZ (1 QT) 946 mL

    image description

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55301-871
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE.3 kg  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55301-871-43.473 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/10/2002
    2NDC:55301-871-45.946 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/10/2002
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/10/2002
    Labeler - Army + Air Force Exchange Service (001695568)
    Registrant - Vi-Jon, LLC (150931459)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi -Jon, LLC150931459manufacture(55301-871)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(55301-871)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(55301-871)

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