Label: POVIDONE IODINE - povidone iodine solution

  • NDC Code(s): 46414-7777-2, 46414-7777-3
  • Packager: James Alexander Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated April 7, 2011

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  • ACTIVE INGREDIENT

    10 percent povidone iodine solution usp 1 percent available iodine topical antiseptic

    topical solution usp swab to prevent infection

    uses to treat minor skin cuts and abrasions

    if swallowed get medical help immediately or contact a Poison Control Center right away.

    For external use only.

    Directions: one swab reverse cardboard sleeve then crush at dot between thumb and forefinger.  Allow solution to saturate tip and apply solution to injury.

    Inactive Ingredients Citric Acid, disodium phosphate, nonoxynol 9, sodium hydroxide, water
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  • PRINCIPAL DISPLAY PANEL

    Povidone Iodine Topical Solution USP Swabs
    povidone inner label
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  • PRINCIPAL DISPLAY PANEL

    Povidone Iodine Topical Solution USP
    povidone outer label
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  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE 
    povidone iodine solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:46414-7777
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Povidone-Iodine (UNII: 85H0HZU99M) (Povidone-Iodine - UNII:85H0HZU99M) Povidone-Iodine .006 g  in 0.6 mL
    Inactive Ingredients
    Ingredient Name Strength
    citric acid (UNII: 2968PHW8QP)  
    phosphate ion (UNII: NK08V8K8HR)  
    nonoxynol-9 (UNII: 48Q180SH9T)  
    sodium hydroxide (UNII: 55X04QC32I)  
    water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46414-7777-3 6 mL in 1 BOX
    2 NDC:46414-7777-2 60 mL in 1 BOX
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 02/14/1976
    Labeler - James Alexander Corporation (040756421)
    Registrant - James Alexander Corporation (040756421)
    Establishment
    Name Address ID/FEI Business Operations
    James Alexander Corporation 040756421 manufacture
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