Label: APLICARE POVIDONE-IODINE SCRUB SMALL WING SPONGE- povidone-iodine scrub solution

  • 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 May 31, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Povidone-iodine USP 10%

  • Purpose

    Antiseptic

  • Use

    • antiseptic skin preparation
  • Warnings

    Do not use

    • if allergic to iodine
    • in the eyes

    Ask a doctor before use if injuries are

    • deep wounds
    • puncture wounds
    • serious burns

    Stop use and ask a doctor if

    • redness, irritation, swelling or pain persists or increases
    • infection occurs

    For external use only

    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

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

  • STORAGE AND HANDLING

    Avoid excessive heat. Store at room temperature.

  • Directions

    use sponges to prep desired area

  • Other information

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

    ammonium nonoxynol-4 sulfate, 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 - 4 Sponge Packet

    NDC 52380-5124-4

    APLICARE

    ◀ Tear Here   Hold Upright   Tear Here ▶

    FOUR POVIDONE-IODINE SCRUB
    SMALL WINGED SPONGES

    ANTISEPTIC
    Non-Sterile Solution

    Four Small Winged Sponges Saturated with
    Povidone-Iodine Scrub USP

    Reorder No. F-4012

    PRINCIPAL DISPLAY PANEL - 4 Sponge Packet
  • INGREDIENTS AND APPEARANCE
    APLICARE POVIDONE-IODINE SCRUB SMALL WING SPONGE 
    povidone-iodine scrub solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-5124
    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, UNSPECIFIED FORM (UNII: GR686LBA74)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52380-5124-4120 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. (107255002)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aplicare, Inc.107255002manufacture(52380-5124)
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