Label: POVIDINE IODINE swab

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated February 10, 2012

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  • ACTIVE INGREDIENT

    Active Ingredient                                  Purpose

    Povidone Iodine 10% v/v                        Antiseptic                          

  • Uses:




    • 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.
  • Warnings:


    • FOR EXTERNAL USE ONLY
  • Do not use:


    • As a first aid antiseptic for more than 1 week.
    • In the eyes.
    • Over large areas of the body.
  • 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 Povidone Iodine Gel Swabstick:

    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


  • Other information:

    Sterile

    Store at room temperature.

    Avoid excessive heat

  • INDICATIONS & USAGE

    For use as an

    • first aid antiseptic
    • pre-operative skin preperation
  • Inactive Ingredients

    Inactive ingredients: citric acid, glycerol, nonoxynol-10, sodium hydroxide, water

  • Principal Display Panel



    PVP_Gel_Swabstick

    PVP_Gel_Swabstick

  • INGREDIENTS AND APPEARANCE
    POVIDINE IODINE 
    povidine iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE10 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    NONOXYNOL-10 (UNII: K7O76887AP)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-301-0110 in 1 CASE
    150 in 1 BOX
    11 in 1 POUCH
    1.3 mL in 1 POUCH
    2NDC:67777-301-0210 in 1 CASE
    225 in 1 BOX
    23 in 1 POUCH
    2.9 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C02/10/2012
    Labeler - Dynarex Corporation (008124539)
    Registrant - Dynarex Corporation (008124539)
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