Label: POVIDONE-IODINE solution

  • NDC Code(s): 53329-938-04, 53329-938-06, 53329-938-08, 53329-938-23, view more
    53329-938-25
  • Packager: Medline Industries, LP
  • 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 March 14, 2022

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  • Active ingredient

    Povidone-Iodine 7.5%

    (equivalent to 0.75% available iodine)

  • Purpose

    Antiseptic

  • Uses

    • for preparation of the skin prior to surgery
    • helps to reduce bacteria that potentially can cause skin infection
    • significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
  • Warnings

    For external use only

    Do not use

    • in the eyes
    • if you are allergic to iodine or any of the other ingredients in the product

    When using this product

    • prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions
    • in pre-operative prepping, avoid “pooling” beneath the patient

    Stop use and ask a doctor

    • if irritation and redness develop
    • if condition persists for more than 72 hours

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison control center right away.

  • Directions

    • apply topically as needed
    • follow with application of Medline Prep Solution and allow to dry
  • Other information

    • protect from freezing, avoid excessive heat
  • Inactive ingredients

    ammonium nonoxynol-4 sulfate, citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

  • Manufactuing Information

    Manufactured by:

    Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in USA

    www.medline.com

    1-800-MEDLINE (633-5463)

    REF: MDS093947

    V1 RB22DYN

  • Package Label

    PDP

  • INGREDIENTS AND APPEARANCE
    POVIDONE-IODINE 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-938
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE0.75 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
    NONOXYNOL-5 (UNII: ED8J5T817W)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-938-06473 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2017
    2NDC:53329-938-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2017
    3NDC:53329-938-23946 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2017
    4NDC:53329-938-253785 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2017
    5NDC:53329-938-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product04/06/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/2007
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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