Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product 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
Documents
Patient Information Leaflets
1.4.4 Betadine Antiseptic Liquid_PIL (Proposed).pdf
Approved: April 21, 2022