Label: POVIDON IODINE PREP PADS- povidone-iodine swab

  • NDC Code(s): 49953-0725-1
  • Packager: Dalian Rongbang Medical Healthy Devices Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 28, 2023

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  • ACTIVE INGREDIENT

    Povidone-Iodine USP 10%

  • PURPOSE

    Antiseptic

  • USE

    Antiseptic Skin Preparation

  • WARNINGS

    For External use only

    Avoid excessive heat. Store at room temperature.

  • DO NOT USE

    Do not use if allergic to iodine

  • STOP USE

    Stop use and ask a doctor if infection occurs or if redness, irriation, swelling or pain persists or increases

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidentla ingestion, seek professional assistance or consult a poision control center immediately

  • DIRECTIONS

    Apply locally as needed

  • OTHER INFORMATION

    1% titratable iodine

    For hospital or professional use only

  • INACTIVE INGREDIENT

    Purified water

  • PRINCIPAL DISPLAY PANEL

    Boxlabel

  • INGREDIENTS AND APPEARANCE
    POVIDON IODINE PREP PADS 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49953-0725
    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
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49953-0725-1100 in 1 BOX02/10/2023
    11 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00302/10/2023
    Labeler - Dalian Rongbang Medical Healthy Devices Co., Ltd. (529882730)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dalian Rongbang Medical Healthy Devices Co., Ltd.529882730manufacture(49953-0725)
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