Label: POVIDONE IODINE - povidone iodine swab

  • NDC Code(s): 49953-1893-1
  • Packager: Dalian Rongbang Medical Healthy Devices Co
  • 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

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

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

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  • INACTIVE INGREDIENT

    Water

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  • DOSAGE & ADMINISTRATION

    1 Swabstick. Apply to procedure site as needed.

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  • INDICATIONS & USAGE

    For professional and hospital use

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

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  • 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.

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  • KEEP OUT OF REACH OF CHILDREN

    Professional and Hosptial use.
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  • PURPOSE

    Apply to procedure site as needed.

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  • PRINCIPAL DISPLAY PANEL

    Povidone-Iodine Swabstick (1's)

    Saturated with: 10% povidone-Iodine, 1% titratable iodine.
    package image
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  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE 
    povidone iodine swab
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:49953-1893
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE 10 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    water (UNII: 059QF0KO0R)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:49953-1893-1 1 mL in 1 POUCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 07/02/2010
    Labeler - Dalian Rongbang Medical Healthy Devices Co (529882730)
    Registrant - Dalian Rongbang Medical Healthy Devices Co (529882730)
    Establishment
    Name Address ID/FEI Business Operations
    Dalian Rongbang Medical Healthy Devices Co 529882730 manufacture
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