FDA.reportPublic FDA data

Profend Nasal Decolonization

Manufacturer
Professional Disposables International, Inc.
Effective date
2025-10-02
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:15:37

Label at a glance#

ProductProfend Nasal Decolonization
Active ingredientPOVIDONE-IODINE
Label structure10 sections

Indications and 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

Dosage and administration

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...

Storage and handling

For hospital and professional use Store at room temperature (15-29 o C; 59-84 o F) Avoid excessive heat

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Sodium Hydroxide

Questions?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Profend

Nasal Decolonization Kit

Povidone-Iodine USP, 10% w/w

Antiseptic

Non-sterile solution

Swabstick

swabstickswabstick

box

boxbox

carton

cartoncarton

insert

insertinsert

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
797730povidone-iodine 10 % Medicated PadPSN12
797730povidone-iodine 100 MG/ML Medicated PadSCD12
797730povidone-iodine 10 % (titratable iodine 1 % ) Medicated PadSY12
797730povidone-iodine 10 % Medicated PadSY12
797730povidone-iodine 10 % Medicated SwabstickSY12

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10819-3888-32024-02-05C16284748780-11030e365-03d1-111a-e063-dadaa90a10e2Profend Nasal Decolonization Kit
10819-3888-32024-01-30C16284748780-11030e365-03d1-111a-e063-dadaa90a10e2Profend Nasal Decolonization Kit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10819-3888-1Profend Nasal Decolonization0.75 mL in 1 TUBE, WITH APPLICATORSWAB0.7512
10819-3888-2Profend Nasal Decolonization4 in 1 BOXSWAB412
10819-3888-3Profend Nasal Decolonization12 in 1 CARTONSWAB1212

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10819-3888-1EA - Each10819-3888f45d24af-157e-4b33-ae7c-7e6196fbd85512024-04-05
10819-3888-2EA - Each10819-3888a1a6c16e-5711-4245-8660-9d559cc8e0b612025-02-10

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10819-388810819-3888-1, 10819-3888-2, 10819-3888-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
POVIDONE-IODINE85H0HZU99MACTIM

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Profend Nasal DecolonizationPOVIDONE IODINE USP, 10% W/WProfessional Disposables International, Inc.6245b1e5-6637-18bc-e053-2a91aa0aa9812025-10-02WarningsExact identifier
ndc (package): 10819-3888-2
ndc (package): 10819-3888-3
ndc (package): 10819-3888-1
ndc (product): 10819-3888
ndc11 (package): 10819388803
ndc11 (package): 10819388802
ndc11 (package): 10819388801
spl id: 40312dd9-3553-cdfb-e063-6394a90a3638
spl set id: 6245b1e5-6637-18bc-e053-2a91aa0aa981

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.