Label: POVIDONE-IODINE PREP PAD- povidone-iodine solution

  • NDC Code(s): 63517-400-83
  • Packager: Cardinal Health 200, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 23, 2023

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  • Drug Facts

  • Active ingredient

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

    Purpose

    First Aid Antiseptic

  • Use

    •first aid to help prevent skin infection in minor cuts, scrapes, and burns

  • Warnings

    For external use only. Do not apply to persons allergic to Iodine Allergy Alert:

    Do not use

    • in the eyes or apply over large areas of the body • longer than one week unless directed by a doctor

    Ask a doctor before use if you have

    • deep or puncture wounds • animal bites • serious burns

    Stop use and consult 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 • apply a small amount of this product on the area 1-3 times daily • may be covered with a sterile bandage • if bandaged, let dry first

  • Other information

    • store at 15°-30°C (59°-86°F)

  • Inactive ingredients

    (purified) water, glycerol, nonylphenol ethoxylate, citric acid, sodium hydroxide

  • Package Labeling:

    Packet Labeling:

    Packet Label

    Box Labeling:

    Box Label

    Carton Labeling:

    Carton Labeling

  • INGREDIENTS AND APPEARANCE
    POVIDONE-IODINE PREP PAD 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63517-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63517-400-8310 in 1 CARTON08/05/2016
    1100 in 1 BOX
    10.56 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00308/05/2016
    Labeler - Cardinal Health 200, Inc. (961027315)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jianerkang Medical Co., Ltd530968767manufacture(63517-400)
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