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

    Saturated with: 10% povidone-Iodine, 1% Titratable Iodine

  • INACTIVE INGREDIENT

    Water

  • DOSAGE & ADMINISTRATION

    1 Swabstick. Apply to procedure site as needed.

  • INDICATIONS & USAGE

    For professional and hospital use

    Apply to procedure site as needed. discard after single use.

  • WARNINGS

    For professional and hospital use.

    For external use only.

    Discard after single use.

    If pain, irritation, redness or swelling occurs, discontinue use and consult a physician.

  • KEEP OUT OF REACH OF CHILDREN

    Professional and Hosptial use.
  • PURPOSE

    Apply to procedure site as needed.

  • PRINCIPAL DISPLAY PANEL

    Povidone-Iodine Swabstick (1's)

    Saturated with: 10% povidone-Iodine, 1% titratable iodine.
    package image
  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE 
    povidone iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49953-1893
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE10 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49953-1893-11 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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