Label: APLICARE POVIDONE-IODINE TRIPLES- povidone-iodine solution

  • NDC Code(s): 52380-5101-1, 52380-5101-2, 52380-5101-3, 52380-5101-5
  • Packager: Aplicare Products, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 August 2, 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

    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.

    Storage Information

    Avoid excessive heat.Store at room temperature.

  • Directions

    • apply locally as needed
  • Other information

    • • 1% titratable iodine
    • • not made with natural rubber latex
    • • for hospital or professional use only
    • • for single 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 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: APLS3111

    0117

  • Package Label

    PRINCIPAL DISPLAY PANEL - 3 Swabstick Packet

  • INGREDIENTS AND APPEARANCE
    APLICARE POVIDONE-IODINE TRIPLES 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-5101
    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
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52380-5101-36.5 mL in 1 PACKET; Type 0: Not a Combination Product05/31/201711/30/2025
    2NDC:52380-5101-225 in 1 BOX05/31/201711/30/2025
    26.5 mL in 1 PACKET; Type 0: Not a Combination Product
    3NDC:52380-5101-1250 in 1 CASE05/31/201711/30/2025
    36.5 mL in 1 PACKET; Type 0: Not a Combination Product
    4NDC:52380-5101-5500 in 1 CASE05/31/201711/30/2025
    46.5 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/31/201711/30/2025
    Labeler - Aplicare Products, LLC (081054904)
    Registrant - Medline Industries, LP (025460908)
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