Label: PROFEND NASAL DECOLONIZATION- povidone iodine usp, 10% w/w swab

  • NDC Code(s): 10819-3888-2, 10819-3888-3
  • Packager: Professional Disposables International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 September 18, 2020

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

  • Active Ingredient

    Povidone-Iodine USP 10% w/w (equivalent to 1.0% titratable iodine)

  • Purpose

    Antiseptic

  • Uses

    • Antiseptic for preparation of skin
    • Helps reduce bacteria that can potentially cause skin infection
    • A broad spectrum antiseptic for topical application for preparation of skin prior to surgery
  • Warnings

    For external use only

    Do not use

    • in the eyes or mouth
    • on individuals who are allergic or sensitive to iodine
    • over large areas of the body

    Stop use and ask doctor if irritation and redness develop or if condition persists for more than 72 hours.

    Ask a doctor before use if you have

    • Deep or puncture wounds
    • animal bites
    • serious burns
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    For nasal application:

    Step 1: Use tissue to clean inside of both nostrils, including inside tips of nostrils. Discard tissue.

    Using total of four swabsticks, perform Steps 2-6 two times for right nostril and two times for left nostril.

    Step 2: Hold applicator tube between thumb and forefinger at blue band with tube in vertical position with tip/handle up. With the other hand, place thumb and forefinger at base of handle (“thumb-to-thumb”).

    Step 3: Bend and snap open along break line.

    Step 4: Bend and snap in opposite direction to disconnect swabstick.

    Step 5: Remove swabstick from tube. Discard tube.

    Step 6: Insert swabstick comfortably into one nostril. For a total of 15 seconds, rotate swabstick around circumference of nostril and then rotate in the anterior nares for a minimum of 6 complete revolutions with slight pressure, covering all surfaces. Discard swabstick.

    Note: Do not blow nose. If solution drips, gently wipe with a tissue.

  • Other information

    • For hospital and professional use
    • Store at room temperature (15-29 oC; 59-84 oF)
    • Avoid excessive heat
  • Inactive Ingredients

    Purified Water, Sodium Hydroxide

  • Questions?

    call 1-800-999-6423 (M-F 9 a.m.-5 p.m. EST)

  • Principal Display Panel

    Profend

    Nasal Decolonization Kit

    Povidone-Iodine USP, 10% w/w

    Antiseptic

    Non-sterile solution

    Swabstick

    swabstick

    box

    box

    carton

    carton

    insert

    insert

  • INGREDIENTS AND APPEARANCE
    PROFEND NASAL DECOLONIZATION 
    povidone iodine usp, 10% w/w swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10819-3888
    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)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10819-3888-312 in 1 CARTON02/16/2018
    1NDC:10819-3888-24 in 1 BOX
    10.75 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/16/2018
    Labeler - Professional Disposables International, Inc. (800777117)
    Establishment
    NameAddressID/FEIBusiness Operations
    Professional Disposables International, Inc.800777117manufacture(10819-3888)