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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 10/13

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

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

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  • Purpose

    Antiseptic

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  • Uses

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

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  • 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.
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  • Other information

    store at 20-25°C (68-77°F)

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  • Inactive Ingredients:

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

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  • Questions?

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

    Patent No. 3M.com/Patents

    Made in U.S.A. by 3M Health Care, 2510 Conway Ave., St. Paul, MN 55144

    © 2012, 3M. 3M is a trademark of 3M.
    34-8710-5699-9

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  • Principal Display Panel – Carton

    3M Skin and Nasal Antiseptic

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

    Patient Preoperative Skin Preparation

    Contents:

    12 pouches

    Each Pouch Contains:

    • 1 Bottle 0.14 fl oz (4 mL)
    • 4 Sterile Swabs

    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

    Principal Display Panel – Carton
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  • Principal Display Panel – Pouch Label

    NDC 17518-060-04

    Latex-Free

    Do Not Reuse

    3M Skin and Nasal Antiseptic

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

    Patient Preoperative Skin Preparation

    Contents:

    • 1 Bottle 0.14 fl oz (4 mL)
    • 4 Sterile Swabs

    REF

    192401

    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

    Principal Display Panel – Pouch Label
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  • INGREDIENTS AND APPEARANCE
    3M SKIN AND NASAL ANTISEPTIC 
    povidone-iodine solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:17518-060
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Povidone-Iodine (Iodine) Iodine 5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    lactic acid  
    malic acid  
    sodium hydroxide  
    sodium iodide  
    steareth-100  
    water  
    xylitol  
    Lauramidopropylamine Oxide  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:17518-060-04 12 in 1 CARTON
    1 1 in 1 POUCH
    1 4 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 07/01/2009
    Labeler - 3M Health Care (006173082)
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