Label: 3M SKIN AND NASAL ANTISEPTIC- povidone-iodine solution

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 1, 2024

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  • SPL UNCLASSIFIED SECTION

    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 wiping solution off during removal.

      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:

    ceteareth-25, lactic acid, lauramidopropylamine oxide, malic acid, polyquarternium-10, PPG-5-ceteth-10 phosphate, sodium hydroxide, sodium iodide, water, xylitol

  • Questions?

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

  • Principal Display Panel – Carton

    3M Skin and Nasal Antiseptic

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

    Patient Preoperative Skin Preparation

    Non-Sterile Solution

    Contents:

    12 pouches

    Each Pouch Contains:

    1 Bottle 0.14 fl oz (4 mL)

    4 Sterile Swabs

    Applicators Are Sterile If Swab Pouch Is Intact

    Made in U.S.A. by

    3M Health Care

    2510 Conway Ave.

    St. Paul, MN 55144

    3M is a trademark of 3M

    1-800-228-3957

    3m.com/Medical

    3M is a trademark of 3M

    © 2021, 3M. All rights reserved.

    34-8726-9172-9

    Principal Display Panel – Carton

  • Principal Display Panel – Pouch Label

    NDC 17518-060-04

    Not Made With Natural Rubber Latex

    Do Not Reuse

    3M Skin and Nasal Antiseptic

    Skin and Nasal Antiseptic

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

    Patient Preoperative

    Skin Preparation

    Non-Sterile Solution

    Each Pouch Contains:

    1 Bottle 0.14 fl oz (4 mL)

    4 Sterile Swabs

    Applicators are sterile if swab pouch is intact

    REF

    192401

    Principal Display Panel – Pouch Label

  • INGREDIENTS AND APPEARANCE
    3M SKIN AND NASAL ANTISEPTIC 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17518-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Povidone-Iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4) Iodine5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Lactic Acid (UNII: 33X04XA5AT)  
    Malic Acid (UNII: 817L1N4CKP)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Sodium Iodide (UNII: F5WR8N145C)  
    ceteareth-25 (UNII: 8FA93U5T67)  
    Water (UNII: 059QF0KO0R)  
    Xylitol (UNII: VCQ006KQ1E)  
    Lauramidopropylamine Oxide (UNII: I6KX160QTV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17518-060-0412 in 1 CARTON07/01/2009
    11 in 1 POUCH
    14 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00307/01/2009
    Labeler - Solventum US OpCo LLC (006173082)
    Establishment
    NameAddressID/FEIBusiness Operations
    3M Company054950670ANALYSIS(17518-060) , LABEL(17518-060) , MANUFACTURE(17518-060) , PACK(17518-060)
    Establishment
    NameAddressID/FEIBusiness Operations
    3M Company078671244MANUFACTURE(17518-060) , ANALYSIS(17518-060)
    Establishment
    NameAddressID/FEIBusiness Operations
    3M Company830016148ANALYSIS(17518-060)
    Establishment
    NameAddressID/FEIBusiness Operations
    BASF040776809API MANUFACTURE(17518-060)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pace Analytical Life Sciences, LLC797903197ANALYSIS(17518-060)
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