Povidone-Iodine

Manufacturer: Medline Industries, LP
Effective date: 2025-10-22
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 01:39:54

Label at a glance#

ProductPovidone-Iodine

Active ingredientPOVIDONE-IODINE

Label structure10 sections

Indications and uses

for preparation of the skin prior to surgery helps to reduce bacteria that potentially can cause skin infection significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care single use when used for patient preoperative skin preparation

Dosage and administration

apply topically as needed

Storage and handling

protect from freezing, avoid excessive heat

Contacts and useful links#

Websitewww.medline.com

www.medline.com

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Povidone-Iodine 7.5% w/v

(equivalent to 0.75% available iodine)

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

for preparation of the skin prior to surgery
helps to reduce bacteria that potentially can cause skin infection
significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
single use when used for patient preoperative skin preparation

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

in the eyes
if you are allergic to iodine or any of the other ingredients in the product

When using this product

OTC - WHEN USING SECTION

prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions
in pre-operative prepping, avoid “pooling” beneath the patient

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation and redness develop
if condition persists for more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

apply topically as needed

Other information

STORAGE AND HANDLING SECTION

protect from freezing, avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

ammonium nonoxynol-4 sulfate, citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

Manufactuing Information

SPL UNCLASSIFIED SECTION

www.medline.com

Manufactured in USA by Medline Industries, LP,

Three Lakes Drive, Northfield, IL 60093 USA.

1-800-MEDLINE

REF: MDS093947

Major Change

RECENT MAJOR CHANGES SECTION

Update to Directions to remove "follow with application of Medline Prep Solution and allow to dry".

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
211747	povidone-iodine 7.5 % Medicated Liquid Soap	PSN	8
211747	povidone-iodine 75 MG/ML Medicated Liquid Soap	SCD	8
211747	povidone-iodine 7.5 % Medicated Liquid Soap	SY	8

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5f30b278-5791-4113-8781-878a9221ef8a	Product name	2	20230125
2a70c781-a755-4d76-b20a-a958acfbdcdc	Product name	2	20190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5	Product name	1	20180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22	Product name	1	20180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5c	Product name	1	20180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896	Product name	1	20170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99	Product name	1	20170309
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8c	Product name	1	20150421

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53329-938-04	Povidone-Iodine	118 mL in 1 BOTTLE	SOLUTION	118	8
53329-938-06	Povidone-Iodine	473 mL in 1 BOTTLE	SOLUTION	473	8
53329-938-08	Povidone-Iodine	237 mL in 1 BOTTLE	SOLUTION	237	8
53329-938-23	Povidone-Iodine	946 mL in 1 BOTTLE	SOLUTION	946	8
53329-938-25	Povidone-Iodine	3785 mL in 1 BOTTLE	SOLUTION	3785	8

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

Povidone-Iodine
AMMONIUM NONOXYNOL-4 SULFATE
NONOXYNOL-5
IODINE
CITRIC ACID MONOHYDRATE
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
SODIUM HYDROXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53329-938	53329-938-06, 53329-938-08, 53329-938-23, 53329-938-25, 53329-938-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
AMMONIUM NONOXYNOL-4 SULFATE	9HIA70O4J0	IACT
NONOXYNOL-5	ED8J5T817W	IACT
POVIDONE-IODINE	85H0HZU99M	ACTIM
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE	94255I6E2T	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
7	2024-12-10	full-release	2026-06-01 00:41:54

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Povidone-Iodine	POVIDONE-IODINE	Medline Industries, LP	2b95078e-2caf-7005-e054-00144ff88e88	2025-10-22	Warnings	Exact identifier ndc (package): 53329-938-23 ndc (package): 53329-938-04 ndc (package): 53329-938-25 ndc (package): 53329-938-08 ndc (package): 53329-938-06 ndc (product): 53329-938 ndc11 (package): 53329093823 ndc11 (package): 53329093808 ndc11 (package): 53329093804 ndc11 (package): 53329093825 ndc11 (package): 53329093806 spl id: 41c65656-ff98-67e5-e063-6394a90a6079 spl set id: 2b95078e-2caf-7005-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.