Label: PVP IODINE- povidone-iodine swab

  • NDC Code(s): 50332-0047-0, 50332-0047-7
  • Packager: HART Health
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 21, 2023

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  • 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

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  • 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)
    Registrant - HART Health (069560969)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jiangsu Province JianErKang Medical530968767manufacture(50332-0047)
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