Label: MEDICHOICE POVIDONE-IODINE PREP PAD- povidone-iodine cloth

  • NDC Code(s): 39892-0808-1
  • Packager: Owens & Minor Distribution, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2023

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  • Drug Facts

  • Active ingredient

    Povidone-iodine USP 10%

    Purpose

    Antiseptic

  • Use

    Antiseptic skin preparation

  • Warnings

    For external use only.

    Do not use

    • if allergic to iodine

    Ask a doctor before use

    if injuries are deep wounds, puncture wounds, or serious burn

    Stop use and ask a doctor

    if infection occurs or if redness, irritation, swelling or pain persists or increases

    Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or consult a poison control center Immediately

    • Avoid excessive heat. Store at room temperature.
  • Directions

    • Apply locally as needed.
  • Other information

    • 1% titratable iodine
    • For hospital or professional use only.
  • Inactive ingredients

    Purified water, Glycerin, Nonyl nonoxynol-10, Citric acid, Sodium hydroxide

  • PRINCIPAL DISPLAY PANEL

    LABEL22

  • INGREDIENTS AND APPEARANCE
    MEDICHOICE POVIDONE-IODINE PREP PAD 
    povidone-iodine cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:39892-0808
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:39892-0808-11 in 1 PACKET03/04/2019
    11 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)03/04/2019
    Labeler - Owens & Minor Distribution, Inc. (847412269)
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