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

Profend Nasal Decolonization by

Drug Labeling and Warnings

Profend Nasal Decolonization by is a Otc medication manufactured, distributed, or labeled by Professional Disposables International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

box

carton

insert

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10819-3888
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10819-3888-3	12 in 1 CARTON	02/16/2018
1	NDC: 10819-3888-2	4 in 1 BOX
1		0.75 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/16/2018

Labeler - Professional Disposables International, Inc. (800777117)

Establishment
Name	Address	ID/FEI	Business Operations
Professional Disposables International, Inc.		800777117	manufacture(10819-3888)