Label: PREP PAD STERILE- povidone-iodine patch

  • NDC Code(s): 59050-456-11
  • Packager: Changzhou Maokang Medical Products Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 15, 2023

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  • Drug Facts

  • Active ingredient

    Povidone-lodine 10%w/w

    Purpose

    Antiseptic

  • Use

    For preparation of the skin prior to surgery

  • Warnings

    • For external use only.
    • Do not apply to persions allergic to iodine.

    Do not use

    in the eyes.

    Ask a doctor before use if

    injuries are deep wounds, puncture wounds, serious burns.

    Keep out of reach of children

    • If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away.
  • Driections

    Clean area. Apply to the operative site prior to surgery

  • Other information

    1% titratable iodine. Store at ambient temperatures.

  • Inactive ingredients:

    Hydroxyethyl cellulose, nonoxynol-10, alkyl glucoside, potassium iodide, sodium hydroxide, glycerin, citric acid, purifed water

  • Package Labeling:

    Label012

  • INGREDIENTS AND APPEARANCE
    PREP PAD STERILE 
    povidone-iodine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59050-456
    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
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59050-456-115.5 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 DrugM00306/29/2018
    Labeler - Changzhou Maokang Medical Products Co., Ltd (421317073)
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