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.
Voluntary notification of medicated oils, balms and medicated plasters
Dealers may voluntarily notify HSA of their MOB and medicated plasters supplied in Singapore. Companies must provide HSA with the relevant documents to demonstrate that their products meet the necessary safety and quality standards. Click here for more information.
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
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
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 102 CFU 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
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
Prohibited ingredients
Under Singapore's legislation, medicated oils and balms locally manufactured or imported for sale in Singapore cannot contain these ingredients or substances:
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
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
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
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