Label: POVIDONE IODINE PREP PADS cloth

  • 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 January 17, 2020

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  • Drug Facts

  • Active Ingredient

    Povidone Iodine 10%

  • Purpose

    Antiseptic

  • Uses

    Antiseptic cleanser to help prevent skin infection in minor cuts, scrapes and burns.

    For preparation of the skin prior to surgery

    Helps reduct bacteria that can potentially cause skin infection

  • Warnings

    For External Use Only

  • Do Not Use

    In the eyes

    As a first aid antiseptic for more than 1 week

    Over large areas of the body

  • Ask doctor before use if you have

    Deep or puncuture wounds

    Animal bites

    Serious wounds

  • Stop Use and ask doctor if

    Condition worsens or persists for more than 72 hours

    Irritation and rednes develops

  • Keep Out of the reach of Children

    If swallowed, get medical help or contact a Poson Control Center immediately

  • 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 first

  • OTHER SAFETY INFORMATION

    Store at room temperature

    Avoid excessive heat

  • Inactive ingredient

    nonoxynol-9, water

  • PRINCIPAL DISPLAY PANEL

    pvp.jpg

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE PREP PADS 
    povidone iodine prep pads cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68183-119
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68183-119-0110 mL in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product10/21/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35610/21/2015
    Labeler - Custom Kits Company Inc (928643712)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dynarex812771980manufacture(68183-119)
    Establishment
    NameAddressID/FEIBusiness Operations
    Custom Kits Company Inc928643712relabel(68183-119) , repack(68183-119)
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