Label: APLICARE POVIDONE IODINE SWABSTICK- povidone-iodine solution

  • NDC Code(s): 52380-4101-1
  • 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 February 27, 2019

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Povidone-iodine USP 10%

  • Purpose

    Antiseptic

  • Use

    antiseptic skin preparation

  • Warnings

    For external use only

    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.

    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
  • Inactive ingredients

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

  • QUESTIONS

    For questions, comments, or to report serious side effects:
    800-760-3236
    Monday-Friday
    8:30 a.m.- 5:00 p.m. EST

  • PRINCIPAL DISPLAY PANEL - 1 Swabstick Packet

    NDC 52380-4101-1

    NPN 02076101

    APLICARE

    ◀              ▶

    ONE
    POVIDONE-IODINE
    SWABSTICK

    ANTISEPTIC
    Non-Sterile Solution

    One 4-inch saturated swabstick

    Reorder No. S-1111

    PRINCIPAL DISPLAY PANEL - 1 Swabstick Packet
  • INGREDIENTS AND APPEARANCE
    APLICARE POVIDONE IODINE SWABSTICK 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-4101
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52380-4101-12 mL in 1 PACKET; Type 0: Not a Combination Product05/31/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/31/2017
    Labeler - Aplicare Products, LLC (081054904)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aplicare Products, LLC081054904manufacture(52380-4101)