Label: POVIDONE-IODINE PREP STERILE- povidone-iodine sponge

  • 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 June 29, 2016

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  • Drug Facts

  • Active ingredient

    Povidone-Iodine USP 10%

    Purpose

    Antiseptic

  • Use

    • For preparation prior to surgery • Helps to reduce bacteria that can potentially cause skin infection.

  • Warnings

    For external use only.

    Do not apply to persons allergic to iodine

    Do not use

    • in the eyes

    Ask a doctor before use if injuries are

    • deep wounds • puncture wounds • serious burns

    Stop use and ask a doctor if

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

    Avoid pooling beneath the patient.

    Prolonged exposure to wet solution may cause skin irritation.

    Keep out of reach of children.

    If swallowed or gets in eyes, get medical help or contact a Poison Control Center right away.

  • Directions

    Clean the area. Apply product to the operative site prior to surgery using sponge sticks to prep desired area.

  • Other information

    • 1% titratable iodine • latex free • for hospital or professional use only

  • Inactive ingredients

    Citric Acid, Alkyl Glucoside, Hydroxyethyl Cellulose, Nonoxynol-10, Glycerin, Sodium Hydroxide, Potassium Iodide, Purified Water

  • Product Label

    BoxLabel

  • INGREDIENTS AND APPEARANCE
    POVIDONE-IODINE PREP STERILE 
    povidone-iodine sponge
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63517-658
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63517-658-1180 g in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug04/30/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/30/2015
    Labeler - Cardinal Health (097537435)
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