Label: APLICARE POVIDONE-IODINE PREP PAD- povidone-iodine solution

  • NDC Code(s): 52380-4111-1, 52380-4111-2
  • Packager: Aplicare, Inc.
  • 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 December 3, 2019

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  • Active Ingredient

    Povidone-iodine USP 10%

  • Purpose

    Antiseptic

  • Use

    antiseptic skin preparation

  • Directions

    Apply locally as needed.

  • Other Information

    • Prep pad size: 1-1/4" × 1-1/2"
    • 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

  • Warnings

    • Do not use if allergic to iodine or in the eyes

    • For external use only

    • Ask a doctor before use if injuries are deep wounds, puncture wounds, or serious burns

    • Stop use and ask a doctor if infection occurs or if 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.
  • STORAGE AND HANDLING

    • Avoid excessive heat. Store at room temperature.
  • PRINCIPAL DISPLAY PANEL - 10 mg Pad Packet

    APLICARE

    NDC 52380-4111-1

    POVIDONE-IODINE PREP PAD

    ANTISEPTIC / Non-Sterile Solution

    Reorder No. APLP1111

    label aplp11118S

  • INGREDIENTS AND APPEARANCE
    APLICARE POVIDONE-IODINE PREP PAD 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-4111
    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)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52380-4111-10.5 mL in 1 PACKET; Type 0: Not a Combination Product05/31/2017
    2NDC:52380-4111-20.5 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, Inc. (081054904)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aplicare Products, LLC081054904manufacture(52380-4111)