Label: APLICARE POVIDONE-IODINE- povidone-iodine solution

  • NDC Code(s): 52380-4801-8
  • 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 10%

    (equivalent to 1% available iodine)

  • Purpose

    Antiseptic

  • Use

    • • antiseptic skin preparation
    • • single use when used for patient preoperative skin preparation
  • 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 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.

  • Directions

    apply topically as needed

  • Other information

    • • 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

  • Manufacturing Information

    Manufactured by:

    Aplicare Products, LLC

    550 Research Parkway, Meriden, CT 06450 USA

    Manufactured for:

    Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in USA with domestic and foreign materials

    1-800-633-5463

    REF: APL82344K

    RL17HND

  • Package Label

    Label

  • INGREDIENTS AND APPEARANCE
    APLICARE POVIDONE-IODINE 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-4801
    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:52380-4801-8118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/1998
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)01/01/1998
    Labeler - Aplicare Products, LLC (081054904)
    Registrant - Medline Industries, LP (025460908)
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