3M Skin and Nasal Antiseptic: Package Insert and Label Information

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.

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.
Figure Figure Figure

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 – Carton
(click image for full-size original)

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
(click image for full-size original)
3M SKIN AND NASAL ANTISEPTIC
povidone-iodine solution
Product Information
Product Type HUMAN OTC DRUG 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 Multilevel Packaging
1 NDC:17518-060-04 12 POUCH in 1 CARTON contains a POUCH
1 1 BOTTLE in 1 POUCH This package is contained within the CARTON (17518-060-04) and contains a BOTTLE
1 4 mL in 1 BOTTLE This package is contained within a POUCH and a CARTON (17518-060-04)
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 Company (006173082)
Establishment
Name Address ID/FEI Operations
3M Company 054950670 ANALYSIS (17518-060), LABEL (17518-060), MANUFACTURE (17518-060), PACK (17518-060)
Establishment
Name Address ID/FEI Operations
3M Company 078671244 MANUFACTURE (17518-060), ANALYSIS (17518-060)
Establishment
Name Address ID/FEI Operations
3M Company 830016148 ANALYSIS (17518-060)
Establishment
Name Address ID/FEI Operations
BASF 040776809 API MANUFACTURE (17518-060)
Establishment
Name Address ID/FEI Operations
Pace Analytical Life Sciences, LLC 797903197 ANALYSIS (17518-060)

Revised: 06/2020 3M Company

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