Profend Nasal Decolonization Kit

Profend Nasal Decolonization Kit
SPL v12
SPL
SPL Set ID 6245b1e5-6637-18bc-e053-2a91aa0aa981
Route
TOPICAL
Published
Effective Date 2018-02-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (10 mg)
Inactive Ingredients
Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-02-16 Until 2028-10-31

Description

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

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

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

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
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.

Questions?

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

Active Ingredient

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

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

Principal Display Panel

Profend

Nasal Decolonization Kit

Povidone-Iodine USP, 10% w/w

Antiseptic

Non-sterile solution

Swabstick

box

carton

insert

Keep Out of Reach of Children.

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


Structured Label Content

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
Purpose

Antiseptic

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
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.

Questions?

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

Active Ingredient

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

Other Information (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

Principal Display Panel

Profend

Nasal Decolonization Kit

Povidone-Iodine USP, 10% w/w

Antiseptic

Non-sterile solution

Swabstick

box

carton

insert

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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