Label: APLICARE POVIDONE-IODINE PERINEAL WASH- povidone-iodine perineal wash liquid

  • 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 March 31, 2010

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  • ACTIVE INGREDIENT

    Povidone-iodine

  • PURPOSE

    Antiseptic

  • ASK DOCTOR

    Stop use and ask a doctor if

    • infection occurs
    • redness, irritation, swelling or pain persists or increases
    Ask a doctor before use if injuries are
    • deep puncture wounds
    • serious burns
  • DO NOT USE

    Do not use if allergic to iodine.

    Do not use in eyes.

  • WARNINGS

    Avoid "pooling" beneath patient.  Prolonged exposure to wet solution may cause skin irritation.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

  • PRINCIPAL DISPLAY PANEL

    Bottle Label

    Perineal Wash Label

  • INGREDIENTS AND APPEARANCE
    APLICARE POVIDONE-IODINE PERINEAL WASH  
    povidone-iodine perineal wash liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-1880
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Povidone-iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4) Povidone-iodine10   in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Nonoxynol-10 (UNII: K7O76887AP)  
    Glycerin (UNII: PDC6A3C0OX)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Sodium Phosphate, Dibasic Anhydrous (UNII: 22ADO53M6F)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52380-1880-8240 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33309/01/1998
    Labeler - Aplicare, Inc. (107255002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aplicare, Inc.058377631manufacture
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