Label: MK POVIDONE-IODINE SWABSTICK NON-STERILE- povidone-iodine liquid

  • 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 December 19, 2018

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  • MK Povidone-Iodine Swabstick Non-Sterile


  • Active ingredient

    Povidone-Iodine USP 10% w/w

    Purpose

    Antiseptic

  • Use:

    antiseptic skin preparation

  • Warnings


    Do not use


    if allergic to Iodine.

    • in the eye

    Stop use and ask a 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 patient.

    Ask a doctor before use if injuries are.

    • deep or puncture wounds
    • serious burns
  • Directions


    apply locally as needed

  • Other information

    • 1% titratable iodine
    • lates free
    • for hospital or prodessional use only
  • Inactive ingredients:

    citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, purified water

  • MK Povidone-Iodine Swabstick Non-Sterile 3 Count (59050-254-10)

    PovidoneIodineSwabstick

  • INGREDIENTS AND APPEARANCE
    MK POVIDONE-IODINE SWABSTICK NON-STERILE 
    povidone-iodine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59050-254
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59050-254-1025 in 1 BOX04/11/2014
    14.5 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/11/2014
    Labeler - Changzhou Maokang Medical Products Co., Ltd (421317073)
    Establishment
    NameAddressID/FEIBusiness Operations
    Changzhou Maokang Medical Products Co., Ltd421317073manufacture(59050-254)
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