Label: POVIDONE-IODINE GEL SWABSTICK NON-STERILE- povidone iodine gel

  • 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 2, 2019

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  • MK Povidone-Iodine Gel Swabstick Non-Sterile

  • Active Ingredient

    Povidone-Iodine USP 10%

    Purpose

    Antiseptic

  • Use

    Antiseptic skin preparation

  • Warnings

    Do not use

    • if allergic to Iodine
    • in the eyes

    Stop use and ask a doctor if

    • rednes, 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 product to skin as needed

  • Other Information

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

    Citric Acid, Alkyl Glucoside, Hydroxyethyl Cellulose, Nonoxynol-10, Glycerin, Sodium Hydroxide, Potassium Iodide, Purified Water

  • MK Povidone-Iodine Gel Swabstick

    item

  • INGREDIENTS AND APPEARANCE
    POVIDONE-IODINE GEL SWABSTICK NON-STERILE 
    povidone iodine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59050-250
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%) (UNII: X70SE62ZAR)  
    POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59050-250-102.3 g in 1 POUCH; Type 0: Not a Combination Product11/05/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/05/2019
    Labeler - Changzhou Maokang Medical Products Co. Ltd (421317073)
    Establishment
    NameAddressID/FEIBusiness Operations
    Changzhou Maokang Medical Products Co. Ltd421317073manufacture(59050-250)
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