3m Skin And Nasal Antiseptic Solution
FDA Label NDC 17518-060

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Solventum Us Llc for the product 3m Skin And Nasal Antiseptic (NDC 17518-060). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - do not use, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

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.

Otc - Do Not Use

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.

Otc - Stop Use

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

Otc - 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.

Directions

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

    • Skin Application:

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

      • Nasal Application:

      • Use a tissue to clean the inside of both nostrils including the inside tip of nostril. Discard.
      • 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.


        • 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)


          • Using a new swab: Repeat steps 2 & 3 with the other nostril. (swab 2)
          • Repeat the application in both nostrils using a fresh swab each time. (swabs 3 & 4)


            • 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. 3M.com/Patents

Made in U.S.A. by 3M Health Care

2510 Conway Ave., St. Paul, MN 55144

3M is a trademark of 3M. © 2017, 3M. 3M. All rights reserved.

34-8721-1989-5

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

    © 2017, 3M. 3M. All rights reserved.

    34-8720-9169-8

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

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