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

  • NDC Code(s): 82996-006-01
  • Packager: Hubei Changjian Medical Products Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 11, 2024

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  • Drug Facts

  • Active ingredients

    Povidone-Iodine 10% w/w

    (1% available iodine)

  • Purpose

    First aid antiseptic

    Pain relieving cream

  • Uses

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

    • For external use only
    • Keep out of reach of children
    • 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 for use:

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

    purified water

  • Package labeling: 82996-006-01

    Antiseptic Povidone-Iodine Prep Pad 82996-006-01

  • INGREDIENTS AND APPEARANCE
    ANTISEPTIC POVIDONE-LODINE PREP PAD 
    povidone-iodine cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82996-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82996-006-011 in 1 POUCH11/01/202204/01/2027
    10.45 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00311/01/202204/01/2027
    Labeler - Hubei Changjian Medical Products Co., Ltd. (699440035)
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