Label: APLICARE- povidone-iodine solution

  • NDC Code(s): 52380-0012-3
  • Packager: Aplicare Products, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2024

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  • Active Ingredient

    Povidone-iodine USP 10% w/v

  • Purpose

    Antiseptic

  • Uses

    • for preparation of the skin prior to surgery
    • helps reduce bacteria that potentially can cause skin infection
  • Warnings

    For external use only

    Do not use

    • if allergic to iodine
    • in the eyes or apply over large areas of the body
    • in case of deep or puncture wounds, animals bites, or serious burns, consult a doctor

    Discontinue use if

    • irritation and redness develop.
    • If condition persists for more than 72 hours consult a doctor

    Avoid pooling beneath patient

    Keep out of reach of children.

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

  • Directions

    antiseptic skin preparation: apply locally as needed.

  • Other information

    • 1% titratable iodine
    • not made with natural rubber latex
    • for hospital or professional use only
    • protect from freezing, avoid excessive heat
    • store at room temperature
  • Inactive ingredients

    alkyl glucoside, citric acid, glycerin, hydroxyethyl cellulose, nonoxynol-10, potassium iodide, purified water, sodium hydroxide

  • Manufacturing information

    www.medline.com ©2024 Medline Industries, LP

    Aplicare is a registered trademark of Medline Industries, LP

    Manufactured for Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    1-800-MEDLINE Made in China. V1 RL24CZU

  • Package Label

    label

  • INGREDIENTS AND APPEARANCE
    APLICARE 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-0012
    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
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID (UNII: 2968PHW8QP)  
    POTASSIUM IODIDE (UNII: 1C4QK22F9J)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52380-0012-322.5 mL in 1 PACKET; Type 0: Not a Combination Product12/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)12/01/2024
    Labeler - Aplicare Products, LLC (081054904)
    Registrant - Medline Industries, LP (025460908)
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