Label: APLICARE POVIDONE IODINE SWABSTICK- povidone iodine solution

  • NDC Code(s): 52380-0038-7
  • Packager: Aplicare Products, LLC
  • Category: HUMAN OTC DRUG LABEL

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 December 15, 2022

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  • Active ingredient

    Povidone-iodine 10%

  • Purpose

    Antiseptic

  • Use

    antiseptic skin preparation

  • Warnings

    For external use only

    Avoid excessive heat. Store between 15-30ºC(59-86ºF).

    Do not use

    • if allergic to iodine
    • in the eyes

    Ask a doctor before use if injuries are

    • deep or 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

    apply locally as needed.

  • Other information

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

  • Inactive ingredient

    disodium phosphate, glycerin, hydroxy ethylcellulose, nonoxynol-10, simethicone, water

  • Manufacturing Information

    Manufactured by: Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093

    Made in USA

    www.medline.com

    1-800-MEDLINE

    Aplicare is a registered trademark of Medline Industries, LP

    REF: APLS1138

    V1 RJ21APL

  • Package Label

    52380-0038 label

  • INGREDIENTS AND APPEARANCE
    APLICARE POVIDONE IODINE SWABSTICK 
    povidone iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-0038
    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
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52380-0038-72 mL in 1 PACKET; Type 0: Not a Combination Product06/01/200308/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/200308/31/2024
    Labeler - Aplicare Products, LLC (081054904)
    Registrant - Medline Industries, LP (025460908)
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