Label: ANTISEPTIC POVIDONE IODINE PREP PAD- povidone-iodine cloth

  • NDC Code(s): 84219-006-00
  • Packager: M-star (Hubei) Health&Care Products Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 1, 2024

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  • Drug Facts

  • Active Ingredients

    Providone-Iodine 10% w/w (1% available iodine)

    Purpose

    Antiseptic

  • Use:

    First aid antiseptic to help prevent the risk of infection in minor cut, scrapes and burns.

  • Warnings:

    • For external use only 
    • Single use only

    Keep out of reach of children

    Do not use:

    • in the eyes
    • over large areas of the body
    • as a first aid antiseptic for longer than one week unless 
    • directed by a physician
    • on individuals who are sensitive or allergic to iodine
    • if package is damaged or open

    Stop use and ask a doctor if

    • irritation,redness,or symptoms develops
    • if the condition persists or gets worse.
  • Directions:

    • Clean the treatment area
    • Apply to the treatment area or operative site before surgery
  • Inactive Ingredient:

    Purified water

  • Question?

    +1(855)924-2182

  • Package Labeling:

    Label00

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC POVIDONE IODINE PREP PAD 
    povidone-iodine cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84219-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84219-006-001 in 1 POUCH05/15/2024
    10.45 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00305/15/2024
    Labeler - M-star (Hubei) Health&Care Products Co., Ltd. (409376382)
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