FDA Label for Profend Nasal Decolonization
View Indications, Usage & Precautions
Profend Nasal Decolonization Product Label
The following document was submitted to the FDA by the labeler of this product Professional Disposables International, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
- Deep or puncture wounds
- animal bites
- serious burns
- if you are pregnant
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
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
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