Label: APLICARE POVIDONE-IODINE- povidone-iodine solution

  • NDC Code(s): 52380-0011-1, 52380-0011-3
  • Packager: Aplicare Products, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 18, 2023

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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
    • 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 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 ingredients

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

  • Manufacturing Information

    Manufactured by:

    Aplicare Products, LLC.

    550 Research Parkway, Meriden, CT 06450

    Made in USA

    1-800-633-5463

    0117

  • Package Label

    front

    back1

    front3

    back3

    Rev V1 RI21APL

  • INGREDIENTS AND APPEARANCE
    APLICARE POVIDONE-IODINE 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-0011
    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)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52380-0011-130 mL in 1 PACKET; Type 0: Not a Combination Product05/31/201711/30/2025
    2NDC:52380-0011-322.5 mL in 1 PACKET; Type 0: Not a Combination Product05/31/201709/30/2026
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00305/31/201709/30/2026
    Labeler - Aplicare Products, LLC (081054904)
    Registrant - Medline Industries, LP (025460908)
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