Label: MK POVIDONE-IODINE SCRUB SOLUTION- povidone-iodine solution

  • 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 June 29, 2020

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  • MK Povidone-Iodine Scrub Solution

  • Active Ingredient

    Povidone-Iodine 10%

    Purpose

    Antiseptic

  • Use

    Antiseptic skin preparation

  • Warnings

    Do not use

    • if allergic to Iodine
    • in the eyes

    Stop use and ask doctor if

    • redness, irritation, swelling or pain persists or increases
    • infection occurs

    Keep out of reach of children

    In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

    Avoid pooling beneath the patient

    Ask a doctor before use if injuries are

    • deep puncture wounds
    • serious burns
  • Directions

    apply locally as needed

  • Other Information

    • 1% titratable
    • for hospital or professional use only
  • Inactive Ingredients

    anhydrous citric acid, sodium dodecyl sulfate, nonoxynol-10, potassium iodide, sodium hydroxide, purified water

  • MK Povidone-Iodine Scrub Solution - 2oz

    2oz

  • MK Povidone-Iodine Scrub Solution - 4oz

    4oz

  • INGREDIENTS AND APPEARANCE
    MK POVIDONE-IODINE SCRUB SOLUTION 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59050-557
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE11 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59050-557-4259 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
    2NDC:59050-557-44118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/10/2020
    Labeler - Changzhou Maokang Medical Products Co. Ltd (421317073)
    Establishment
    NameAddressID/FEIBusiness Operations
    Changzhou Maokang Medical Products Co. Ltd421317073manufacture(59050-557)
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