Label: NON-STERILE- povidone-iodine patch

  • NDC Code(s): 59050-553-11
  • Packager: Changzhou Maokang Medical Products Co., Ltd
  • 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 September 12, 2018

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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 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
  • Driections

    apply locally as needed

  • Other information

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

    Citrc Acid, Alkyl Glucoside, Hydroxyethy, Cellulose, Nonoxynol-10, Glycerin, Sodium Hydroxide, Potassium lodide, Purifed Water.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    NON-STERILE 
    povidone-iodine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59050-553
    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)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59050-553-1122.5 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 not finalpart333E06/29/2018
    Labeler - Changzhou Maokang Medical Products Co., Ltd (421317073)
    Establishment
    NameAddressID/FEIBusiness Operations
    Changzhou Maokang Medical Products Co., Ltd421317073manufacture(59050-553)
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