3M SKIN AND NASAL ANTISEPTIC- povidone-iodine solution 
3M Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Patient Preoperative Skin Preparation

Drug Facts

Active Ingredient

Povidone-Iodine USP, 5%
(0.5% Available Iodine)

Purpose

Antiseptic

Uses

  • For preparation of the skin prior to surgery
  • Helps reduce bacteria that potentially can cause skin infections

Warnings

For external use only.

Do not use if you have a known sensitivity to iodine or any other ingredient in this product. Do not use in eyes. If product gets into eyes, flush immediately with water. Do not use on infants less than 2 months old due to the risk of increased blood iodine levels.

Stop use and ask a doctor if significant irritation, sensitization or other allergic reactions occur.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Open package and remove bottle and swabs
  • Unscrew cap by turning cap counter-clockwise

Skin Application:

  1. Apply to clean dry skin.
  2. Dip one swab into solution and stir vigorously for 10 seconds. Withdraw the swab slowly to avoid wiping solution off during removal.
  3. Scrub prep site for 2 minutes working from clean to dirty using both sides of the swab.
  4. Repeat steps 2 & 3 using second swab.
  5. Allow prep solution to dry. Do not blot.

Nasal Application:

  1. Use a tissue to clean the inside of both nostrils including the inside tip of nostril. Discard.
  2. Tilting the bottle slightly, dip one swab into solution and stir vigorously for 10 seconds. Withdraw the swab slowly to avoid
    Figure
  3. Insert swab comfortably into one nostril and rotate for 15 seconds covering all surfaces. Then focus on the inside tip of nostril and rotate for an additional 15 seconds. (swab 1)
    Figure
  4. Using a new swab: Repeat steps 2& 3 with the other nostril. (swab 2)
  5. Repeat the application in both nostrils using a fresh swab each time. (swabs 3 & 4)
    Figure
  6. Do not blow nose. If solution drips out of nose, it can be lightly dabbed with at tissue.

Other information • Store at 20-25°C (68-77°F)

Inactive Ingredients: lactic acid, lauramidopropylamine oxide, malic acid, polyquarternium-10, PPG-5-ceteth-10 phosphate, sodium hydroxide, sodium iodide, steareth-100, water, xylitol

Questions?

Call 1 800-228-3957 (Monday to Friday 7 am to 6 pm CST) www.3M.com

Patent No. US 7,147,873

Made in U.S.A. by 3M Health Care, St. Paul, MN 55144-1000

© 3M 2009 3M is a trademark of 3M. 34-8702-4279-8

PACKAGE LABEL

NDC 17518-060-04

1 Bottle 0.14 fl oz (4 mL)

4 Sterile Swabs

3M™ Skin and Nasal Antiseptic

Povidone-Iodine Solution 5% w/w (0.5% Available Iodine) USP

Patient Preoperative Skin Preparation

Equivalent to 5mg available Iodine per milliliter

OTC Monograph Not Final

3M Health Care, St. Paul, MN 55144-1000

Figure
3M SKIN AND NASAL ANTISEPTIC 
3m skin and nasal antiseptic solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17518-060
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Povidone-Iodine (Povidone-Iodine) Povidone-Iodine5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
lactic acid 
malic acid 
sodium hydroxide 
sodium iodide 
polyoxyl 100 stearate 
water 
xylitol 
Packaging
#Item CodePackage Description
1NDC:17518-060-044 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33307/01/2009
Labeler - 3M Company (006173082)
Establishment
NameAddressID/FEIBusiness Operations
3M ESPE Dental Products799975909MANUFACTURE

Revised: 12/2009
Document Id: 7953ceaf-71d3-47d2-9b03-481ea61170c0
Set id: 1a94494d-7dd3-4f32-bc42-81c199fe233e
Version: 1
Effective Time: 20091218
 
3M Company