Label: APLICARE POVIDONE-IODINE- povidone-iodine solution

  • NDC Code(s): 52380-1905-0, 52380-1905-2, 52380-1905-3, 52380-1905-4, view more
    52380-1905-6, 52380-1905-7, 52380-1905-8, 52380-1905-9
  • Packager: Aplicare Products, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 8, 2024

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  • Active ingredient

    Povidone-iodine USP 10%

  • Purpose

    Antiseptic

  • Warnings

    For external use only

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

    Do not use

    • in the eyes
    • on individuals allergic or sensitive to iodine

    Ask a doctor before use if injuries are

    • deep or puncture wounds
    • serious burns

    Stop use and ask a doctor if

    • infection occurs
    • 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.

  • Uses

    • antiseptic skin preparation
    • single use when used for patient preoperative skin preparation and/or preinjection indications.
  • 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

  • Questions or comments?

    1 800-633-5463

    Monday - Friday

    8:30 AM -5:00 PM EST

  • Manufacturing Information

    Manufactured by:
    Aplicare Products, LLC
    550 Research Parkway, Meriden, CT 06450 USA

    Made in USA with domestic and foreign materials
    1-800-633-5463
    REF: APL82332
    RL17HND

  • Package Label

    Label RL17HND

  • INGREDIENTS AND APPEARANCE
    APLICARE POVIDONE-IODINE 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-1905
    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:52380-1905-260 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/199806/01/2022
    2NDC:52380-1905-4120 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/199806/01/2022
    3NDC:52380-1905-8240 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/199806/01/2022
    4NDC:52380-1905-6480 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/199807/31/2021
    5NDC:52380-1905-7960 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/199803/31/2022
    6NDC:52380-1905-93800 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/199806/01/2022
    7NDC:52380-1905-390 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/1998
    8NDC:52380-1905-060 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/01/1998
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)09/01/1998
    Labeler - Aplicare Products, LLC (081054904)
    Registrant - Medline Industries, LP (025460908)
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