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
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.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/09/04 | Not Applicable | Completed | Elif Asena KANTARCI | ||
2025/07/01 | Not Applicable | Not yet recruiting | |||
2025/04/30 | Not Applicable | Completed | Federal Teaching Hospital Abakaliki | ||
2025/04/20 | Not Applicable | Completed | Federal Teaching Hospital Abakaliki | ||
2024/12/20 | Phase 4 | Recruiting | |||
2024/09/27 | Phase 2 | Recruiting | |||
2024/09/13 | Not Applicable | Completed | |||
2024/06/18 | Phase 2 | Not yet recruiting | |||
2024/05/20 | Not Applicable | Not yet recruiting | |||
2024/05/06 | Not Applicable | Active, not recruiting |
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. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
BETADINE GARGLE AND MOUTH WASH | N/A | N/A | N/A | 12/19/1979 | |
VIDENE SURGICAL SCRUB 0.75% | N/A | N/A | N/A | 10/24/1995 | |
BETADINE ANTISEPTIC OINT | N/A | N/A | N/A | 12/19/1979 | |
BETADINE VAGINAL PESSARIES | N/A | N/A | N/A | 12/19/1979 | |
BETADINE VC KIT | N/A | N/A | N/A | 12/19/1979 | |
BETADINE CREAM 5% | N/A | N/A | N/A | 11/27/1991 | |
BETADINE THROAT SPRAY 0.45% W/V | N/A | N/A | N/A | 9/7/2015 | |
BETADINE ALCOHOLIC SOLN | N/A | N/A | N/A | 4/18/1980 | |
BETADINE DRY POWDER SPRAY 2.5% W/W | N/A | N/A | N/A | 7/21/1987 | |
BETADINE VAGINAL GEL 10% W/W | N/A | N/A | N/A | 3/11/2014 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
---|---|---|---|---|---|
BETADINE ANTISEPTIC OINTMENT povidone-iodine 100mg/g tube | 29561 | Medicine | A | 10/25/1991 | |
BETADINE ANTISEPTIC SOLUTION povidone-iodine 100mg/mL paint bottle | 29562 | Medicine | A | 10/25/1991 | |
APOHEALTH READY TO USE SORE THROAT GARGLE povidone-iodine 1% w/v bottle | 410251 | Medicine | A | 6/8/2023 | |
PHARMACY HEALTH POVIDONE-IODINE CONCENTRATED SORE THROAT GARGLE povidone-iodine 7.5% w/v solution bottle | 463370 | Medicine | A | 10/1/2024 | |
Alcoholic Povidone-Iodine 10% Solution | 11298 | Medicine | A | 8/13/1991 | |
BETADINE ALCOHOLIC SKIN PREP. solution bottle | 29557 | Medicine | A | 10/25/1991 | |
PERRIGO ANTISEPTIC SOLUTION povidone-iodine 100 mg/mL solution bottle | 252853 | Medicine | A | 8/5/2015 | |
Povidone Iodine Solution 10% w/v Cutaneous Solution 100mL | 279512 | Medicine | A | 8/24/2016 | |
INNODINE CONCENTRATED SORE THROAT GARGLE povidone-iodine 7.5% solution bottle | 410656 | Medicine | A | 6/15/2023 | |
PHARMACY CHOICE POVIDONE-IODINE READY TO USE SORE THROAT GARGLE povidone-iodine 1% w/v mouthwash bottle | 462371 | Medicine | A | 9/18/2024 |
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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