Label: APLICARE POVIDONE-IODINE PAINT- povidone-iodine 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 June 1, 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.

    Avoid excessive heat. Store at room temperature.

  • Directions

    use sponge sticks 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

    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 - 2 Sponge Sticks Packet

    NDC 52380-4011-2

    APLICARE

    ◀ Tear Here   Hold Upright   Tear Here ▶

    TWO POVIDONE-IODINE PAINT
    SPONGE STICKS

    ANTISEPTIC
    Non-Sterile Solution

    Two 8-inch Sponge Sticks Saturated with
    Povidone-Iodine USP, 1% Available Iodine

    Reorder No. F-2011

    PRINCIPAL DISPLAY PANEL - 2 Sponge Sticks Packet
  • INGREDIENTS AND APPEARANCE
    APLICARE POVIDONE-IODINE PAINT 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-4011
    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:52380-4011-22 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(52380-4011)
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