Label: POVIDONE IODINE solution

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 22, 2023

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  • Active ingredient

    Active Ingredient                                  Purpose

    Povidone Iodine 10% v/v                        Antiseptic                          

  • Uses


    • First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.
    • Healthcare antiseptic for preparation of the skin prior to surgery.
    • Antiseptic cleanser for preparation of skin prior to an infection.
  • Warnings

    • FOR EXTERNAL USE ONLY
  • Do not use


    • As a first aid antiseptic for more than 1 week unless directed by a doctor.
    • In the eyes.
    • Over large areas of the body.
    • On individuals who are allergic  or sensitive to iodine.
  • Ask a doctor before use if you have

    • Deep puncture wounds
    • Animal bites
    • Serious burns
  • Stop Use

    • If irritation and redness develop
    • If condition persists for more than 72 hours, consult a physician.
  • Keep Out Of Reach Of Children

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center.


  • Directions

    As a first aid antiseptic

    • clean affected area
    • apply a small amount of this product to the area1 to 3 times daily
    • may be covered with a sterile bandage, if bandaged let dry.

    For preoperative patient skin preparation

    • clean area
    • apply to operative site prior to surgery using the applicator
  • Inactive Ingredient

    • citric acid
    • glycerin
    • sodium citrate
    • tween 80
    • disodium phosphate
    • purified Water
  • INDICATIONS & USAGE

    For use as an

    • first aid antiseptic
    • pre-operative skin preperation
  • Principal Display Panel

    Povidone Iodine

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE 
    povidone iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-1103
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-1103-09237 mL in 1 BOTTLE; Type 0: Not a Combination Product12/21/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00312/21/2011
    Labeler - Major Pharmaceuticals (191427277)