Medicated oils, balms and medicated plasters

Understand the requirements to import, manufacture or sell medicated oils, balms and medicated plasters in Singapore.

What are medicated oils, balms and medicated plasters

Medicated oils, balms (MOB) and medicated plasters refer to any external medicated embrocation, medicated cream, ointment, inhalant or plaster which are mainly used for soothing purposes and may contain one or more of the following substances as active ingredients:

Any essential oil
Any fixed oil derived from a plant
Methyl salicylate
Menthol
Camphor
Peppermint

MOB exclude products that are used in aromatic diffusers and as fragrances. Medicated plasters exclude products that are used in wound dressings.

Food and supplements of food nature come under the purview of the Singapore Food Agency (SFA). View the interactive Food-Health Product Classification Tree1517 KB for more information.

Is my product a complementary health product (CHP)?

Answer a few questions in our self-help tool to find out if your product is considered a complementary health product (e.g. Chinese Proprietary Medicine, Health Supplement, Traditional Medicine) in Singapore.

You can also get a print-out of your product classification outcome from the tool.Let's go

Want to know more about CHP product classification? Click here for our FAQ.

Regulatory requirements of medicated oils, balms and medicated plasters

MOB and medicated plasters are not subject to approvals and licensing by HSA for their importation, manufacture and sales. HSA prohibits the addition of medicinal ingredients such as steroids in MOB and medicated plasters. HSA also sets strict limits on toxic heavy metals in these products. Dealers (importers, manufacturers, wholesale dealers and sellers) have the obligation to ensure that their products are not harmful or unsafe, and that they conform with the following guidelines before supplying MOB and medicated plasters into Singapore.

Toxic heavy metal limits

Your product must not exceed the following heavy metal limits:

Heavy metal	Permissible limits
Arsenic	5 parts per million (ppm)
Cadmium	0.3ppm
Lead	10ppm
Mercury	0.5ppm

Microbial limits

Your product must not exceed the following microbial limits:

Microbe	Microbial limits
Total aerobic microbial count	Not more than 10⁴ CFU per g or ml
Yeast and mould count	Not more than 5 x 10²CFU per g or ml
Pseudomonas aeruginosa and Staphyloccocus aureus	Absent in 1g or ml

Notwithstanding the limits stated above, it is the obligation of the dealers and sellers to ensure that the microbial content and heavy metals of the product is appropriate and safe when used according to the recommended conditions of use and target users. Dealers are encouraged to comply to the ASEAN Guidelines on the Limits of Contaminants for microbial limits. The applicable guidelines is posted at the ASEAN website (click on "POLICY & GUIDELINES" under "Key Documents & Publications" to expand the section and refer to point 11).

Labelling requirements

Your product label should include the ingredients and their strengths in English. You are also not allowed to claim or indirectly suggest that the product will prevent, alleviate or cure any of the following conditions:

Blindness
Cancer
Cataract
Drug addiction
Deafness
Diabetes
Epilepsy or fits
Hypertension
Insanity
Kidney diseases
Leprosy
Menstrual disorder
Paralysis
Tuberculosis
Sexual function
Infertility
Impotency
Frigidity
Conception and pregnancy

Dealers must ensure that all health claims and information associated with the products are sufficiently supported and submitted to HSA as and when required. Otherwise, all unsubstantiated health claims and information will be considered misleading and must be removed from the product materials.

Prohibited ingredients

Under Singapore's legislation, medicated oils and balms locally manufactured or imported for sale in Singapore cannot contain these ingredients or substances:

Any other substances except those stated on the labels.
Substances listed in the Schedule of the Poisons Act.
Western medicines.
Ingredients listed in the ASEAN Guiding Principles from the Negative List of Substances for Traditional Medicines319 KB.

Transmissible Spongiform Encephalopathy (TSE)

Animal derived ingredients

Transmissible spongiform encephalopathy (TSE) refers to a group of progressive diseases including scrapie in sheep and goats, chronic wasting disease in mule, deer and elk, bovine spongiform encephalopathy (BSE) in cattle, as well as Kuru and Creutzfeldt-Jakob Disease (CJD) in humans.

The infectious agents causing these diseases replicate and cause neurological disorders and eventual death in the infected individuals. There are currently no early diagnostic tests or known therapies for these diseases.

If your product contains animal derived ingredients, you must comply with our TSE guidelines236 KB to minimise the risk of TSE transmission.

Substances from endangered species

If your product contains substances from endangered species listed under the Endangered Species (Import & Export) Act, you should contact the Wildlife Management Group of NParks to obtain the necessary Convention on the International Trade in Endangered Species of Wild Fauna and Flora (CITES) import and export permits.

Quality standards

Your product needs to achieve acceptable standards of quality in terms of:

Product stability and shelf life
Storage conditions and distribution practices
Manufacturing, packaging and assembly conditions

Please refer to the following guidelines for more information:

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.

To complement the traditional medicines, homoeopathic medicines, MOB and medicated plasters Guidelines, a list of questions and answers on the controls, safety and quality, claims and labelling can be found here142 KB

Good Manufacturing Practice (GMP) Certificate and Certificate of a Pharmaceutical Product (CPP)

Use our guides below if you wish to apply for a GMP certificate or a CPP.

Free Sale Certificate (FSC)

Some importing countries may require a certificate to show that the product is currently sold and distributed in Singapore.

As such, local exporters may apply for a FSC from the Health Sciences Authority.

Each FSC is specific to one product and allows the inclusion of up to five importing countries. Information in the FSC includes:

Name of product
Importing countries
Name and address of the manufacture(s) and distributor(s)
Intended use
Ingredients
Date of Issue of the FSC

Last updated: 31 Dec 2018