Skip to main content
A Singapore Government Agency Website

Medicated oils and balms

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

What are medicated oils and balms

Medicated oils and balms refer to any external medicated embrocation, medicated cream, ointment or inhalant which are mainly used for soothing purposes and 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

Medicated oils and balms exclude products that are used in aromatic diffusers and as fragrances.

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.

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

Regulatory requirements of medicated oils and balms

Medicated oils and balms 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 medicated oils and balms. 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 medicated oils and balms 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 10CFU 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:

  1. Blindness
  2. Cancer
  3. Cataract
  4. Drug addiction
  5. Deafness
  6. Diabetes
  7. Epilepsy or fits
  8. Hypertension
  9. Insanity
  10. Kidney diseases
  11. Leprosy
  12. Menstrual disorder
  13. Paralysis
  14. Tuberculosis
  15. Sexual function
  16. Infertility
  17. Impotency
  18. Frigidity
  19. 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.

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 and medicated oils and balms Guidelines, a list of questions and answers on the controls, safety and quality, claims and labelling can be found here88 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.