Label: POVIDONE-IODINE PREP- povidone-iodine patch

  • 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 28, 2017

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  • Drug Facts

  • Active ingredient

    Povidon-Iodin 10% (w/w)

    (equivalent to 1% titratable iodine)

    Purpose

    Antiseptic

  • Uses

    • First aid antiseptic to help prevent infection in minor cuts, scrapes and burns
  • Warnings

    • For external use only

    Do not use

    • in the eyes or apply over large areas of the body
    • longer than 1 week unless directed by a doctor
    • on individuals who are sensitive or allergic to iodine

    Stop use and ask a doctor if

    • irritation and redness develop 
    • condition persists more than 72 hours
    • in case of deep or puncture wounds, animal bites or serious burns

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • Clean the treatment area
    • Apply a small amount of this product on the area 1~3 times daily 
    • may be covered with a sterile bandage
    • if bandaged, let dry first
  • Inactive ingredient

    • Purified water
  • Other information

    • Store at room temperature: 15°C~30°C(59°F~86°F)
    • Avoid excessive heat
  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    POVIDONE-IODINE PREP 
    povidone-iodine patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44019-100
    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
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44019-100-001 in 1 POUCH07/07/2017
    10.45 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 finalpart333A07/07/2017
    Labeler - Yinjing Medical Technology (Shanghai) Co., Ltd. (530501535)
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