MedPath
HSA Approval

BETADINE® ANTISEPTIC LIQUID 10% W/V

SIN15699P

BETADINE® ANTISEPTIC LIQUID 10% W/V

BETADINE® ANTISEPTIC LIQUID 10% W/V

May 28, 2019

MUNDIPHARMA PHARMACEUTICALS PTE. LTD.

MUNDIPHARMA PHARMACEUTICALS PTE. LTD.

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantMUNDIPHARMA PHARMACEUTICALS PTE. LTD.
Licence HolderMUNDIPHARMA PHARMACEUTICALS PTE. LTD.

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
General Sale List
HSA Singapore Classification

Formulation Information

LIQUID

**How much and how often should you use this medicine?** For external use only. _Wounds, burns, cuts and abrasions:_ Apply the solution, undiluted, onto areas to be treated and allow to dry. Air-permeable film is formed which can be easily washed off with water. The solution can be applied several times daily, for maximum of 14 days. _Disinfection of the hands:_ Apply onto the palm and lather with hands and fingers for up to 1 minute. The natural golden brown colour of **BETADINE® Antiseptic Liquid** easily identifies the areas that has been washed. Areas that are not golden brown in colour indicates further handwashing is required. Rinse thoroughly with water. **BETADINE® Antiseptic Liquid** is not recommended for continuous daily use throughout the year. _Before surgery:_ Apply to all areas of skin with special attention to skin folds such as the armpit, groin and anal area. Avoid pooling both under the patient and in the skin folds. Skin burns due to ‘pooling’ may occur. Remove any jewelry before use especially silver articles. **BETADINE® Antiseptic Liquid** should not cover large areas of the skin (e.g. not to cover more than 10% of the total body surface) and for not longer than 14 days.

TOPICAL

Medical Information

**What is this medicine used for?** **BETADINE® Antiseptic Liquid** is indicated for - Management of minor wounds, including prevention of infection in burns, cuts, and abrasions - Disinfection for hand hygiene including during periods of infectious disease outbreaks - Disinfection of the skin before an operation

**When you should not use?** **BETADINE® Antiseptic Liquid** should not be used: - If you are allergic to povidone iodine or any ingredients in the product - If you have a thyroid problem - If you are to receive or are currently receiving radioactive iodine treatments - If you are using products containing mercury such as thiomersal - In children under 1 year of age

D08AG02

povidone-iodine

Manufacturer Information

MUNDIPHARMA PHARMACEUTICALS PTE. LTD.

Mundipharma Pharmaceuticals Ltd

Active Ingredients

Povidone Iodine

10.000% w/v

Povidone-iodine

Documents

Patient Information Leaflets

1.4.4 Betadine Antiseptic Liquid_PIL (Proposed).pdf

Approved: April 21, 2022

Download

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

BETADINE® ANTISEPTIC LIQUID 10% W/V - HSA Approval | MedPath