Label: POVIDONE IODINE- povidone-iodine swab

  • 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 30, 2017

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  • Drug Facts


  • Active Ingredients

    Povidone-Iodine 10% w/w
    (1% titratable iodine)

  • Purpose

    Antiseptic

  • Use

    First aid antiseptic to help prevent infection in scrapes, minor cuts and burns Antiseptic to prepare skin prior to surgery. Uses antiseptic skin preparation

  • Stop Use Section

    Stop use and ask a doctor if skin irritation, redness, swelling, or pain occurs.

  • Warnings Section

    Warnings • Do not use if allergic to iodine • For external use only • Do not use in eyes • Avoid pooling beneath patient • In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

  • Keep Out of Reach of Children Section

    Keep out of reach of children.

  • Directions Section

    Directions apply locally as needed

  • Inactive Ingredients Section

    Inactive ingredients Sodium hydroxide, water

  • Other Information Section

    Other information
    For Hospital or Professional Use Only.
    Store at room temperature: 15℃- 30 ℃

  • SPL UNCLASSIFIED SECTION

    For professional and hospital use
    Store at room temperature
    LOT                           EXP.

  • PRINCIPAL DISPLAY PANEL

    IN IN
    NDC:44019-236-01

    POVIDONE-IODINE SWABSTICK

    For External Use Only

    1 swabstick/packet

  • Product Label

    Povidone-iodine Swabstick(1pack)Povidone-iodine swabstick(3pack)

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44019-236
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44019-236-011 in 1 PACKET08/03/2016
    11.6 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:44019-236-033 in 1 PACKET08/03/2016
    25 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/03/2016
    Labeler - Yinjing Medical Technology (Shanghai) Co., Ltd. (530501535)
    Registrant - Yinjing Medical Technology (Shanghai) Co., Ltd. (530501535)
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