Label: POVIDONE IODINE PREP- povidone iodine solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 December 12, 2022

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  • Active ingredient

    Povidone Iodine 10%

    (equivalent to 1% titratable iodine)


  • Purpose

    Antiseptic/First Aid Antispetic


  • Uses

    • First aid to help prevent skin infection in minor cuts,scrapes, and burns
    • For preparation of the skin prior to skin surgery
    • Helps to reduce bacteria that can potentially cause skin infection
  • Warnings

    For External Use Only.


    Do not use

    As a first aid antiseptic



    • Do not use in the eyes or apply over large areas of the body
    • In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor
    • Stop use and consult a doctor if the condition persists or gets worse
    • Do not use longer than 1 week unless directed by a doctor

    For preoperative patient skin preparation



    • Do not use in the eyes
    • Discontinue use if irritation and redness develop
    • If condition persists for more than 72 hours, consult a doctor



    Keep out of reach of children.

    • If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    Clean the affected area.



    For preparation of skin prior to surgery

    • Apply product to the operative site prior to surgery

    For first aid antiseptic

    • 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

    • Protect from freezing
    • Avoid excessive heat

  • Inactive Ingredients:

    Citric Acid, Disodium Phosphate, Nonoxynol-9, Sodium Hydroxide, Water


  • Principal Display Panel

    Povidone-Iodine Prep Solution

    Povidone-Iodine 10%

    single use only

    Cardinal Health

    Net Wt. 0.75 fl oz (22.2 mL)

    NDC 63517-132-01



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  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE PREP 
    povidone iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63517-132
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63517-132-01500 in 1 CASE08/25/2016
    122.2 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C08/26/2015
    Labeler - Cardinal Health (961027315)
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