Label: APLICARE POVIDONE-IODINE- povidone-iodine ointment

  • NDC Code(s): 52380-0126-2
  • Packager: Aplicare Products, LLC
  • 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 February 16, 2023

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  • Active Ingredient

    Povidone-iodine USP 10%

  • Purpose

    Antiseptic

  • Use

    antiseptic skin preparation

  • Warnings

    • For external use only

    Do not use

    • if allergic to iodine or in the eyes

    Ask a doctor before use if injuries are

    • deep wounds, puncture wounds, or serious burns

    Stop use and ask a doctor

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

    Keep out of reach of children.

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

    • Avoid excessive heat. Store at room temperature.
  • Directions

    Apply locally as needed.

  • Other Information

    • 1% titratable iodine
    • Not made with natural rubber latex
    • for hospital or professional use only
  • Inactive ingredients

    glycerin, polyethylene glycol, propylene glycol

  • Package Label

    PRINCIPAL DISPLAY PANEL - 1 gram Ointment Packet

  • INGREDIENTS AND APPEARANCE
    APLICARE POVIDONE-IODINE 
    povidone-iodine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-0126
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYETHYLENE GLYCOL 1450 (UNII: OJ4Z5Z32L4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52380-0126-21 g in 1 PACKET; Type 0: Not a Combination Product05/31/201712/31/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/31/201712/31/2025
    Labeler - Aplicare Products, LLC (081054904)
    Registrant - Medline Industries, LP (025460908)
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