PROFEND NASAL DECOLONIZATION- povidone iodine usp, 10% w/w swab 
Professional Disposables International, Inc.

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.

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Profend Nasal Decolonization Kit

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

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)

Revised: 9/2020
 
Professional Disposables International, Inc.