Active ingredients in topical antiseptics
Topical antiseptics should contain well-established active ingredients documented to be safe and effective antiseptic in internationally recognised, evidence-based scientific references, such as the following:
Examples of active ingredients in topical antiseptics may include the following:
- Benzalkonium chloride
- Benzethonium chloride
- Hydrogen peroxide
- Iodine / Povidone iodine
Active ingredients used in topical antiseptics should meet pharmacopeia quality standards. Based on the United Stated Pharmacopeia, the European Pharmacopeia and the British Pharmacopeia, the acceptable level of impurities in ethanol, as active ingredient, should be i) methanol ≤ 200µL/L, ii) acetaldehyde ≤ 10µL/L and iii) benzene ≤ 2µL/L. Methanol should not be used to denature alcohol for use in hand sanitisers as there are safer denaturants available such as denatonium benzoate, sucrose octaacetate.
Prohibited ingredients in topical antiseptics
Topical antiseptics must not contain ingredients listed in the Poisons Act and its Rules (Cap. 234) and the Second Schedule to the Health Products (Therapeutic Products) Regulations.
Prohibition of mercury-added topical antiseptics to comply with the Minamata Convention on Mercury
The Minamata Convention on Mercury is an international treaty to protect human health and environment from man-made releases of mercury and mercury compounds. Currently, there are over 110 countries, including Singapore, who are parties to this convention.
As a party, one of the obligations is to phase out the manufacture, import or export of the mercury-added products by 2020. With effect from 1 January 2020, the manufacture, import or export of topical antiseptics with mercury or any compound of mercury will not be allowed.