Profend Nasal Antiseptic Kit Swab
FDA Label NDC 10819-3889

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Professional Disposables International, Inc. for the product Profend Nasal Antiseptic Kit (NDC 10819-3889). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel

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.