Label: POVIDONE IODINE swab

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 2, 2010

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  • ACTIVE INGREDIENT

    10% povidone-iodine solution equivalent to 1% available iodine.
  • INACTIVE INGREDIENT

    not listed on label

  • DOSAGE & ADMINISTRATION

    1 pad. for external use only

  • INDICATIONS & USAGE

    Clean intended area thoroughly with pad. discard after single use.

  • KEEP OUT OF REACH OF CHILDREN

    for professional and hospital use.

  • WARNINGS



    store at room temperature. In case of deep or puncture wounds or serious burns, and if pain, irritation, redness, swellling, or infection occurs, discontinue use and contact a physician. See drug facts panel on box. For external use only.

  • PURPOSE

    Clean intended area.

  • PRINCIPAL DISPLAY PANEL

    Rongbang Antiseptic, Povidone-Iodine, USP, Prep Pad, Mediumcarton image

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE 
    povidone iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49953-2805
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Povidone-Iodine (UNII: 85H0HZU99M) (Povidone-Iodine - UNII:85H0HZU99M) Povidone-Iodine1 mL  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49953-2805-11 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C07/02/2010
    Labeler - Dalian Rongbang Medical Healthy Devices Co (529882730)
    Registrant - Dalian Rongbang Medical Healthy Devices Co (529882730)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dalian Rongbang Medical Healthy Devices Co529882730manufacture
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