Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
SPRAY
**How much and how often should you use this medicine?** For use in adults and children over 6 years of age. One spray into the back of the throat every 3–4 hours as needed, to a maximum of three sprays a day.
ORAL
Medical Information
**What is this medicine used for?** **BETADINE** ® **Sore Throat Spray** is indicated for protection and symptomatic relief of sore throat and mouth ulcers. For oral hygiene prior to, during and after dental and oral surgery.
**When should you not take this medicine?** This medicine should be avoided: - If you have an allergy to iodine or any ingredients in **BETADINE** ® **Sore Throat Spray** - If you have a thyroid problem - In children under 6 years of age - If you are to receive or currently receiving radioactive iodine treatments - If you are pregnant or breast feeding
R02AA15
povidone-iodine
Manufacturer Information
MUNDIPHARMA PHARMACEUTICALS PTE. LTD.
Mundipharma Pharmaceuticals Ltd
Active Ingredients
Documents
Patient Information Leaflets
1.4.4 Throat Spray_PIL (Proposed).pdf
Approved: April 21, 2022