Regulatory overview of topical antiseptics

Understand the requirements to import, manufacture or sell topical antiseptics in Singapore.

What are topical antiseptics 

Topical antiseptics refer to products that are placed in contact with external parts of the human body or mucosal membranes of the oral and nasal cavity to kill microorganism, or to inhibit or prevent the growth of microorganism, with the primary intent to limit or prevent infection.  

Topical antiseptics may include products such as:

  • hygienic hand rub or sanitizers
  • wound disinfectants
  • pre-surgical skin disinfectants

Topical antiseptics do not include products with the primary intent for cosmetic function such as cleansing purpose (for example skin cleanser, hand wash). Refer to our cosmetic products section for more information on cosmetic products.

Regulatory requirements of topical antiseptics

We regulate topical antiseptics in Singapore under the following legislation:

  1. Medicines Act (Chapter 176) and its subsidiary legislation especially:
    • Medicines (Traditional Medicines, Homeopathic Medicines and Other Substances) (Exemption) Order
    • Medicines (Prohibition of Sale & Supply) Order
    • Medicines (Medical Advertisements) Regulations
    • Medicines (Labelling) Regulations
  2. Medicines (Advertisement and Sale) Act (Chapter 177)

Topical antiseptics are not subject to approval and licensing by HSA for their importation, manufacture and sales in Singapore.

Dealers (manufacturers, importers, wholesale dealers and sellers) must ensure that their products are not harmful or unsafe, and that they conform to the following guidelines and applicable quality standards before supplying topical antiseptics in Singapore.

Suppliers can refer to this guidance for more information. 

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:

  • Ethanol
  • Benzalkonium chloride
  • Benzethonium chloride
  • Cetrimide
  • Chlorhexidine
  • Hydrogen peroxide
  • Iodine / Povidone iodine
  • 1-propanol
  • 2-propanol
  • Biphenyl-2-ol

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.

Topical antiseptics product claims

A product claim refers to any message or representation made on a product in relation to its indications, benefits or actions, which may be stated directly or inferred indirectly through, but not limited to, the following:

  • Product or brand name
  • Product label(s) or packaging
  • Graphics or logos on product packaging
  • Product brochures or information sheets distributed with/separately from the product
  • Point of sales materials
  • Media advertisements (print, sound and light & sound)

General principles for claims in topical antiseptics

The product must not make any claim or reference to:

  • A specific infection, disease or disorder, including its related conditions
  • Any effectiveness against a specific microorganism or a specific class of microorganism.

Any claim made for topical antiseptics must not be false or misleading in any way by ambiguity, exaggeration, omission or otherwise imply about the product’s contents, quality, safety or that the product has properties and benefits beyond that of a general disinfection purpose.

All claims made should be substantiated by internationally recognised, evidence-based scientific references (such as Martindale, AHFS Drug Information, pharmaceutical pharmacopoeias) or supported by robust scientific data from well-designed, controlled studies relevant to the use on humans.

Examples of acceptable claims for topical antiseptics may include the following:

  • antiseptic hand rub
  • hygienic hand sanitizer
  • kill germs
  • antimicrobial
  • wound cleansing
  • wound disinfection

Labelling requirements

The product label should be presented in English language and printed in a clear and legible manner. It should contain adequate and truthful information to enable consumers to make informed decisions and use the product correctly. The types of information include:

  • Product name
  • Name of the active ingredient(s)
  • Quantitative particulars of the active ingredient(s)
  • Intended use
  • Direction for use
  • Expiry date (or “Use by”, “Use before”, or words with similar meaning)
  • Appropriate cautionary label or statement, including
    • "For external use only"
    • "Flammable. Keep away from heat or flame” for alcohol-based products

Advertisements and promotions

Advertisements and promotions

You will require a valid permit from us before publishing any medical advertisement or conducting any sales promotion activity directed at the general public.

Refer to our advertisements and promotions guidelines for more information on what is required before you run any advertisement or promotion for your products.