NDC Code(s) : 17518-060-04
Packager : Solventum US OpCo LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

3M Skin and Nasal AntisepticPovidone-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(UNII: 85H0HZU99M)
(Iodine - UNII:9679TC07X4) 		Iodine5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
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 Code Package Description Marketing Start Date Marketing End Date
1NDC:17518-060-0412 in 1 CARTON 07/01/2009
11 in 1 POUCH
14 mL in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M003 07/01/2009

LABELER - Solventum US OpCo LLC(006173082)

Establishment
Name Address ID/FEI Business Operations
3M Company 054950670 ANALYSIS(17518-060), LABEL(17518-060), MANUFACTURE(17518-060), PACK(17518-060)

Establishment
Name Address ID/FEI Business Operations
3M Company 078671244 MANUFACTURE(17518-060), ANALYSIS(17518-060)

Establishment
Name Address ID/FEI Business Operations
3M Company 830016148 ANALYSIS(17518-060)

Establishment
Name Address ID/FEI Business Operations
BASF 040776809 API MANUFACTURE(17518-060)

Establishment
Name Address ID/FEI Business Operations
Pace Analytical Life Sciences, LLC 797903197 ANALYSIS(17518-060)

PRINCIPAL DISPLAY PANEL

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

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