Label: STERILE- povidone-iodine patch

  • NDC Code(s): 59050-552-11
  • Packager: Changzhou Maokang Medical Products Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 21, 2024

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  • Drug Facts

  • Active ingredient

    Povidone-lodine 10%w/w

    Purpose

    Antiseptic

  • Use

    for antiseptic skin preparation

  • Warnings

    do not use

    • if allergic to lodine
    • do not use in the eyes

    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
  • Driections

    Apply product to skin as needed.

  • Other information

    • 1% titratable iodine
    • for hospital or professional use only
  • Inactive ingredients:

    Alkyl glucoside,citric acid,glycerin, hydroxyethyl cellulose,nonoxynol-10, potassium iodide, purified water, hydroxode

  • Package Labeling:

    Label8

  • INGREDIENTS AND APPEARANCE
    STERILE 
    povidone-iodine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59050-552
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59050-552-1122.5 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)06/29/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/29/2018
    Labeler - Changzhou Maokang Medical Products Co., Ltd (421317073)
    Establishment
    NameAddressID/FEIBusiness Operations
    Changzhou Maokang Medical Products Co., Ltd421317073manufacture(59050-552)
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