Label: POVIDINE IODINE - povidine iodine swab

  • 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 May 9, 2011

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient                                  Purpose

    Povidone Iodine 10% v/v                        Antiseptic                          

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  • Uses:povidone iodine swabstick 3



    • First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns.
    • For preparation of the skin prior to surgery.
    • Helps reduce bacteria that can potentially cause skin infections.
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  • Warnings:

    • FOR EXTERNAL USE ONLY
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  • Do not use:


    • As a first aid antiseptic for more than 1 week.
    • In the eyes.
    • Over large areas of the body.
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  • Ask a doctor before use if you have:


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


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

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


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  • Directions:

    Tear at notch, remove applicator, use only once.

    As a first aid antiseptic

    • clean affected area
    • apply 1 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


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  • Inactive Ingredient:povidone_iodine_swabstick

    Inactive Ingredient: Nonoxynol-9, Water
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  • INDICATIONS & USAGE

    For use as an

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

    povidone_iodine_swabstick

    povidone_iodine_swabstick

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  • INGREDIENTS AND APPEARANCE
    POVIDINE IODINE 
    povidine iodine swab
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0404-5639
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE 10 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0404-5639-01 10 in 1 CASE
    1 25 in 1 BOX
    1 3 in 1 POUCH
    1 .9 mL in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 03/17/2011
    Labeler - Henry Schein Inc (012430880)
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