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Povidone-iodine

Generic Name
Povidone-iodine
Brand Names
Betadine, Kenalog, Marbeta, Marcaine, P-Care M, P-Care MG, P-care, P-care X, Summer's Eve Medicated
Drug Type
Small Molecule
CAS Number
25655-41-8
Unique Ingredient Identifier
85H0HZU99M

Overview

Povidone-iodine is a stable chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine. It contains from 9.0% to 12.0% available iodine, calculated on a dry basis. This unique complex was discovered in 1955 at the Industrial Toxicology Laboratories in Philadelphia by H. A. Shelanski and M. V. Shelanski. During in vitro testing to demonstrate anti-bacterial activity it was found that the complex was less toxic in mice than tincture of iodine. Human clinical trials showed the product to be superior to other iodine formulations. Povidone-iodine was immediately marketed, and has since become the universally preferred iodine antiseptic.

Indication

For topical application in the treatment and prevention of infection in wounds.

Associated Conditions

  • Skin Infections

Research Report

Published: Jul 28, 2025

A Comprehensive Pharmacological and Clinical Monograph of Povidone-Iodine (DB06812)

Executive Summary

Povidone-iodine (PVP-I), identified by DrugBank ID DB06812, is a cornerstone of modern antisepsis. It exists as a stable chemical complex of elemental iodine with the polymer polyvinylpyrrolidone (PVP), a formulation designed to overcome the significant limitations of historical iodine tinctures. This monograph provides an exhaustive analysis of its chemical properties, historical context, pharmacological profile, clinical utility, and safety considerations. The development of PVP-I in 1955 marked a pivotal advancement, creating an "iodophor" that acts as a reservoir, providing sustained release of free iodine. This mechanism confers a broad-spectrum microbicidal activity against bacteria (including antibiotic-resistant strains), viruses, fungi, and protozoa, while significantly reducing the local irritation and systemic toxicity associated with elemental iodine solutions.

The mechanism of action is multifactorial, involving the rapid penetration of microbial cells by free iodine, followed by the denaturation of essential proteins, oxidation of cellular lipids, and disruption of nucleic acids. This multi-pronged attack makes the development of microbial resistance exceedingly rare. Clinically, PVP-I is utilized across a vast range of applications, from pre- and post-operative skin disinfection and surgical hand scrubbing to first aid for minor wounds, management of chronic ulcers, ophthalmic prophylaxis, and oropharyngeal decontamination. It is available in numerous formulations, including solutions, scrubs, ointments, powders, and specialized preparations for vaginal and ocular use, with concentrations tailored to specific applications.

Continue reading the full research report

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Rite Aid
11822-9050
TOPICAL
10 mg in 1 mL
8/12/2025
Atlantis Consumer Healthcare Inc
67618-155
TOPICAL
5 mg in 1 mL
4/18/2025
Rebel Distributors Corp
42254-006
OPHTHALMIC
5 mg in 1 mL
2/17/2009
Aplicare Products, LLC
52380-2802
TOPICAL
7.5 mg in 1 mL
9/2/2025
Shield Line LLC
52410-4114
TOPICAL
100 mg in 1 mL
8/18/2025
Atlantis Consumer Healthcare, Inc.
67618-150
TOPICAL
10 mg in 1 mL
4/17/2025
Acme United Corporation
0924-5408
TOPICAL
10 mg in 1 mL
6/17/2025
Consolidated Horse Products
86208-100
TOPICAL
10 g in 100 g
8/12/2025
Lights Medical Manufacture Co., Ltd.
61333-216
TOPICAL
0.75 g in 100 g
5/20/2025
Hua Jing Medical Supplies INC.
83170-003
TOPICAL
10 mg in 100 mg
5/1/2025

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
BETADINE® ANTISEPTIC LIQUID 10% W/V
SIN15699P
LIQUID
10.000% w/v
5/28/2019
BETADINE SORE THROAT SPRAY 0.45% W/V
SIN15313P
SPRAY
0.45% w/v
8/7/2017
BETADINE VAGINAL GEL 10% W/W
SIN15344P
GEL
10% w/w
10/13/2017

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
ACU DYNE SKIN CLEANSER
ACME UNITED CORPORATION
00394823
Liquid - Topical
7.5 %
12/31/1976
BETADINE SOLUTION SWAB AID 10%
purdue pharma
00276731
Dressing - Topical
1 MG / PCK
12/31/1973
POVIDONE-IODINE SCRUB
aplicare inc.
02076098
Solution - Topical
7.5 %
11/14/1996
PROVIODINE GEL
rougier pharma division of ratiopharm inc
00026611
Gel - Vaginal
10 %
12/31/1964
ONE TIME ACU DYNE PREP SWAB
ACME UNITED CORPORATION
00393630
Liquid - Topical
10 %
12/31/1977
JAMSHIDI BONE MARROW BIOPSY TRAY
allegiance healthcare corporation
01975536
Liquid - Topical ,  Block/Infiltration ,  Subcutaneous
1 % / KIT
12/31/1992
BETADINE SHAMPOO 7.5%
purdue pharma
00158321
Shampoo - Topical
7.5 %
12/31/1966
PERSIST POVIDONE IODINE PREP
becton dickinson
02213362
Liquid - Topical
10 %
8/12/1997
CENTRAL VENOUS CATHETER EXPANDED KIT
edwards lifesciences (canada) inc.
01980718
Liquid ,  Kit ,  Ointment - Subcutaneous ,  Parenteral (Unspecified) ,  Block/Infiltration ,  Topical
10 %
12/31/1992
PROVIODINE DOUCHE VAGINALE
rougier pharma division of ratiopharm inc
00252824
Liquid - Vaginal
10 %
12/31/1972

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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