Label: POVIDONE IODINE solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 November 18, 2022

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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 finalpart333C12/21/2011
    Labeler - Major Pharmaceuticals (191427277)