Label: APLICARE POVIDONE-IODINE PAINT- povidone-iodine solution

  • NDC Code(s): 52380-0101-5
  • Packager: Aplicare Products, LLC
  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated November 29, 2021

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  • Active ingredient

    Povidone-iodine USP 10%

  • Purpose

    Antiseptic

  • Use

    antiseptic skin preparation

  • Warnings

    For external use only

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

    Avoid excessive heat. Store at room temperature.

    Do not use

    • if allergic to iodine
    • in the eyes

    Ask a doctor before use if injuries are

    • deep wounds
    • puncture wounds
    • serious burns

    Stop use and ask a doctor if

    • redness, irritation, swelling or pain persists or increases
    • infection occurs

    Keep out of reach of children.

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

  • Directions

    use sponge sticks to prep desired area

  • Other information

    • for single use only
    • not made with natural rubber latex
    • for hospital or professional use only
  • Inactive ingredients

    citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

  • Package Label

    label

  • INGREDIENTS AND APPEARANCE
    APLICARE POVIDONE-IODINE PAINT 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-0101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52380-0101-52 in 1 PACKAGE03/01/1992
    152.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/01/1992
    Labeler - Aplicare Products, LLC (081054904)
    Registrant - Medline Industries, LP (025460908)