Label: MEDICHOICE PVP- povidone-iodine swab

  • NDC Code(s): 39892-0811-1, 39892-0811-2
  • Packager: Owens & Minor Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 9, 2023

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  • Drug Facts

  • Active ingredient

    Povidone Iodine USP,10% w/w

    Purpose

    Antiseptic

  • Use

    For preparation of the skin prior to surgery and helps reduce bacteria that can potentially cause skin infection. Topical first aid antiseptic to help reduce the risk of skin infection in minor cuts, scrapes, and burns.

  • Warnings

    For external use only.

    Do not use 

    • in the eyes 
    • on individuals who are allergic or sensitive to iodine 
    • over large areas of the body 
    • as a first aid antiseptic longer than one week unless directed by a doctor.

    Consult a doctor

    • in case of deep or puncture wounds, animal bites, or serious burns.

    Stop use and consult a doctor

    • if irritation or redness develops 
    • if the condition persists or gets worse 
    • infection occurs.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    For preparation prior to surgery Clean the treatment area Remove swab by stick Apply to the operative site prior to surgery. Clean the treatment area Apply a small amount on the treatment area 1-3 times daily May be covered with a sterile bandage Let dry before covering.






    For use as a first aid antiseptic

  • Other information

    • Store at room temperature.
    • Avoid excessive heat.
  • Inactive ingredient

    Citric Acid, Alkyl Glucoside, Hydroxyethyl Cellulose, Nonoxyno-10, Glycerine, Sodium Hydroxide, Potassium Iodide, Purified Water

  • Package Labeling:

    Label5Box4

  • MediChoice PVP Swabsticks, 1000 Count (39892-0811-2)

    Label3Case

  • INGREDIENTS AND APPEARANCE
    MEDICHOICE PVP 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:39892-0811
    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:39892-0811-110 in 1 CASE08/29/2017
    150 in 1 BOX
    11 in 1 PACKAGE
    13 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:39892-0811-21000 in 1 CASE08/29/2017
    22.5 g 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)08/29/2017
    Labeler - Owens & Minor Inc. (847412269)
    Registrant - Owens & Minor Inc. (847412269)
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