HYDROGEN PEROXIDE LIQUID [AFASSCO INC.]

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HYDROGEN PEROXIDE LIQUID [AFASSCO INC.]
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NDC 51532-5400-1
Set ID d8979711-4d8f-4363-99c3-865f9c2c7e48
Category HUMAN OTC DRUG LABEL
Packager Afassco Inc.
Generic Name
Product Class
Product Number
Application Number PART333A
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Hydrogen Peroxide 3.0%

  • Purpose

    First Aid Antiseptic

  • Uses

    First aid to help prevent infection in minor cuts, scrapes and burns

  • Warnings

    For external use only.

    Do not use

    • near eyes or mucous membranes
    • on deep or puncture wounds, animal bites, or serious burns

    Keep out of reach of children.

    Caution

    • not for use on large areas of the body
    • if redness, irritation, swelling or pain persists or increases, discontinue use and consult a physician
  • Directions

    • spray over affected area
    • if bandaged, let dry first
  • Inactive ingredients

    purified water

  • PRINCIPAL DISPLAY PANEL – 2 oz. bottle label

    Hydrogen
    Peroxide
    Spray

    First Aid Antiseptic Spray

    • Cleans and Irrigates Wounds
    • Fights Infection

    #625 2 Fl. Oz. (59 mL)

    Mfd. For
    Afassco
    MINDEN, NV 89423

    PRINCIPAL DISPLAY PANEL – 2 oz. bottle label
  • INGREDIENTS AND APPEARANCE
    HYDROGEN PEROXIDE 
    hydrogen peroxide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51532-5400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    hydrogen peroxide (UNII: BBX060AN9V) (hydrogen peroxide - UNII:BBX060AN9V) hydrogen peroxide30 mL  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51532-5400-10.059 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/16/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/16/2012
    Labeler - Afassco Inc. (609982723)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(51532-5400)
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