HYDROGEN PEROXIDE SOLUTION [SOUND BODY]

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HYDROGEN PEROXIDE SOLUTION [SOUND BODY]
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NDC 11344-002-43, 11344-002-45
Set ID 6d1a2cd9-64b3-4bc1-9665-41702e23688a
Category HUMAN OTC DRUG LABEL
Packager Sound Body
Generic Name
Product Class
Product Number
Application Number PART333A
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  • Active ingredient

    Hydrogen peroxide (stabilized) 3%

  • Purpose

    First Aid Antiseptic

  • Use

    first aid to help prevent the risk of infection in minor cuts, scrapes and burns

  • Warnings

    For external use only

  • Do not use

    • in the eyes or apply over large areas of the body
    • longer than one 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

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • clean the affected area
    • apply a small amount of the product on the affected area 1 to 3 times a day
    • may be covered with a sterile bandage
    • if bandaged, let dry first
  • Other information

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

  • Inactive ingredients

    purified water

  • adverse reactions

    Manufactured for Big Lots

    By:Vi-Jon, Inc

    8515 Page Avenue

    St. Louis, MO 63114

    V#425040 Item 100051394

  • principal display panel

    SOUNDBODY

    First Aid Antiseptic

    HYDROGEN

    PEROXIDE

    Topical Solution

    3% USP

    First Aid Antiseptic

    For treatment of minor cuts and abrasions

    8 FL OZ (236 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-002
    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:11344-002-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/08/2014
    2NDC:11344-002-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/08/2014
    3NDC:11344-002-34236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/08/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/08/2014
    Labeler - Sound Body (150931459)
    Registrant - Vi-Jon (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture(11344-002)
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