3m™ Skin And Nasal Antiseptic

3m™ Skin And Nasal Antiseptic
SPL v9
SPL
SPL Set ID 1a94494d-7dd3-4f32-bc42-81c199fe233e
Route
TOPICAL
Published
Effective Date 2024-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (5 mg)
Inactive Ingredients
Lactic Acid Malic Acid Sodium Hydroxide Sodium Iodide Ceteareth-25 Water Xylitol Lauramidopropylamine Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-07-01

Description

Drug Facts

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Drug Facts

Uses
  • For preparation of the skin prior to surgery
  • Helps reduce bacteria that potentially can cause skin infections
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

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

Section 50570-1

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.

Warnings

For external use only.

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.
Questions?

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

Active Ingredient

Povidone-Iodine USP, 5%

(0.5% Available Iodine)

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

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 – 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


Structured Label Content

Uses
  • For preparation of the skin prior to surgery
  • Helps reduce bacteria that potentially can cause skin infections
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50570-1 (50570-1)

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.

Purpose

Antiseptic

Warnings

For external use only.

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.
Questions?

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

Active Ingredient

Povidone-Iodine USP, 5%

(0.5% Available Iodine)

Other Information (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

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 – 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


Advanced Ingredient Data


Raw Label Data

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