PVP IODINE (POVIDONE-IODINE) SWAB [HART HEALTH]

PVP IODINE (POVIDONE-IODINE) SWAB [HART HEALTH]
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NDC 50332-0047-0, 50332-0047-7
Set ID 06b085dd-934d-40e9-aa0d-2dd9cdccd535
Category HUMAN OTC DRUG LABEL
Packager HART Health
Generic Name
Product Class
Product Number
Application Number PART333A
  • Active Ingredient

    Povidone Iodine 10% (equivalent to 1% titratable iodine)

  • Purpose

    Topical Antiseptic

  • Uses

    First aid topical antiseptic to help prevent infection in:

    • minor cuts
    • scrapes
    • burns
    • abrasions
  • Warnings

    For external use only

  • Do not use

    • in the eyes or over large portions of the body
    • on serious burns
    • on animal bites
    • on deep or puncture wounds
  • Stop use and ask a doctor if

    • symptoms last more than 72 hours
    • redness, swelling, irritation or pain occurs
  • Keep out of reach of children

    If swallowed get medical help or contact a Poison Control Center right away 1-800-222-1222

  • Directions

    Adults and children 12 years of age and over:

    • apply topically to clean affected area 1 to 3 times daily
    • when dry, may be covered with a sterile bandage
    • if gets in eyes, flush thoroughly with water

    Children under 12 years of age:

    • ask a doctor
  • Inactive Ingredients

    Citric Acid, Glyercin, Nonoxynol, Sodium Hydroxide, Water

  • PRINCIPAL DISPLAY PANEL

    6161PVP100.jpg

  • INGREDIENTS AND APPEARANCE
    PVP IODINE 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0047
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE.10 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50332-0047-010 in 1 BOX04/01/1974
    1.35 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:50332-0047-7100 in 1 BOX04/20/2016
    2.35 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/01/1974
    Labeler - HART Health (069560969)

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