HYDROGEN PEROXIDE SOLUTION [TOPCO ASSOCIATES]

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HYDROGEN PEROXIDE SOLUTION [TOPCO ASSOCIATES]
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NDC 36800-871-34, 36800-871-72
Set ID c3509fd3-e1bc-42bd-881e-7fb520ace9f9
Category HUMAN OTC DRUG LABEL
Packager TOPCO ASSOCIATES
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 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
  • Keep out of reach of children.

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

  • Directions

    • clean the affected area
    • spray 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 away from face when opening.

  • Inactive ingredient

    purified water

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007

    QUESTIONS? 1-888-423-0139 topcare@topco.com

  • principal display panel

    TOPCARE

    FIRST AID ANTSEPTIC

    Hydrogen Peroxide Topical Solution USP

    • For treatments of minor cuts and abrasions

    10 FL OZ (295 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-871
    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:36800-871-34237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2015
    2NDC:36800-871-72295 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/31/2015
    3NDC:36800-871-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2015
    4NDC:36800-871-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/31/2015
    Labeler - TOPCO ASSOCIATES (006935977)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(36800-871)
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