Guidelines for Labelling Standards of HS and TM Sep 2023
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 2 of 9
Content:
1. Introduction
2. Labelling Standards
3. References
Appendix 1 – Labelling Information
Page
3
3
4
5
Guidelines for Labelling Standards of HS and TM Sep 2023
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 3 of 9
1. Introduction
1.1 Dealers of health supplements (HS), traditional medicines (TM), medicated oils,
balms (MOB) and medicated plasters are required to ensure that their products
are labelled properly. Labels are used for product identification and provide
relevant information to enable consumers to ensure safe and appropriate use of
the product, store the product correctly and make informed purchase decisions.
1.2 The objective of these guidelines is to provide guidance for labelling standards in
Singapore, to ensure proper labelling of these products.
2. Labelling Standards
2.1 Labelling refers to any printed or graphic representation that appears on or is
attached to the product or any part of its packaging and includes a leaflet, if any
that accompanies the product when it is being supplied.
2.2 All product labelling must be in English. Labelling information in other languages,
if any, should be consistent with the English text.
2.3 The information on the product label should be adequate and truthful.
2.4 All labelling of containers and packages of HS, TM, MOB or medicated plaster
should be printed or marked in a legible and indelible manner.
2.5 The following are the different types of product labels:
• Outer label refers to the product packaging in which the immediate packaging
of the finished product is contained, e.g., the package or carton box containing
the bottle, strips or blister packs.
• Inner label refers to the label affixed on the primary container of the finished
product, e.g., the immediate label affixed to a bottle where the finished product
is contained.
• Small label refers to the label on a small primary container, usually a unit
dose container, e.g., sachets or small single dose bottle.
• Strip or blister pack label refers to the label affixed or printed on the strip or
blister pack.
2.6 Table 1 provides the labelling information required for each product label type
and leaflet.
Guidelines for Labelling Standards of HS and TM Sep 2023
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 4 of 9
Table 1 Labelling Standards
Information
Outer
Label
Inner
Label
Small Label,
Strip or
Blister Pack
Label
Leaflet,
if any
1. Product Name including Brand
Name
✓
✓
✓
✓
2. Dosage Form
✓
✓*
N/A***
✓
3. Name and Quantity of Active
Ingredients
✓
✓
N/A***
✓
4. Intended Purpose
✓
✓
N/A***
✓
5. Dosage and Directions of
Use
✓
✓
N/A***
✓
6. Batch Number
✓
✓
✓
N/A
7. Expiry Date
✓
✓
✓
N/A
8. Country of Manufacture
✓
✓*
N/A***
N/A
9. Name and Address of Local
Importer (for overseas
manufactured product) or
Product Owner (for locally
manufactured product)
✓
✓*
N/A***
N/A
10. Contraindications, if any
✓
✓*
N/A***
✓
11. Other warnings, if any
✓**
✓*
N/A***
✓
12. Storage Condition
✓
✓*
N/A***
✓
13. Pack Size / Net Content
✓
✓*
N/A***
✓
* May be omitted if the product is supplied with an outer label
** May be omitted if the accompanying product leaflet provides this information
*** The small label, strip or blister pack label should minimally display the product
name, batch number and expiry date. In such instances, the full product
information should be displayed on the label of an accompanying outer carton
box
2.7 The inclusion of a leaflet is optional. Information provided within the leaflet should
be consistent with that presented on the outer or inner label. Companies who are
interested to implement an electronic product leaflet are to refer to the Guidelines
on Voluntary Electronic Labelling for Complementary Health Products
2.8 More explanation on the labelling information can be found in Appendix 1.
3. References
3.1 ASEAN Guidelines on Labelling Requirements for Health Supplements
3.2 ASEAN Guidelines on Labelling Requirements for Traditional Medicines
Guidelines for Labelling Standards of HS and TM Sep 2023
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 5 of 9
Appendix 1 – Labelling Information
1. Brand Name and Product Name
“Brand Name” generally refers to a name given by the company or manufacturer
to a product or range of products. A product may or may not have a “Brand
Name”. “Product Name” refers to the name given to a specific product to
distinguish itself from other similar products in the market.
Refer to the Guidelines for Claims and Claims Substantiation of Health
Supplements and Traditional Medicines for guidance on the appropriate brand
name and product name.
2. Dosage Form
“Dosage Form” refers to the final physical form of the product that contains the
active ingredient(s) and may be used directly by the consumer, e.g., tablet,
capsule, soft gel, liquid, etc.
3. Name and Quantity of Active Ingredients
“Active ingredient” refers to the ingredient that contributes to the intended function
of the product. It is recommended that internationally accepted nomenclature be
used for ingredient names.
The name and quantity of plants or animals from which the active ingredient is
derived should be declared in its scientific name followed by the plant or animal
part constituting the active component, and type of preparation where applicable.
The use of the common or local name of the plant or animal is optional.
Table 2 Examples of Naming of Active Ingredients
Full Labelling Name
Scientific
Name
Part
Type of
Preparation
Common
Name
1. Eurycoma longifolia,
root, 200mg, extract
100:1 equivalent to
20,000mg of fresh
root (Tongkat Ali)
Eurycoma
longifolia
Root
Extract 100:1,
equivalent to
20,000mg of
fresh root
Tongkat Ali
2. Silybum marianum,
seed, 200mg, extract
standardised to 80%
silymarin (Milk Thistle)
Silybum
marianum
Seed
Extract
standardised
to 80% silymarin
Milk Thistle
3. Withania somnifera,
root, 125mg, extract
dry concentration
(Ashwagandha)
Withania
somnifera
Root
Extract dry
concentration
Ashwagandha
For vitamins and minerals, the common or chemical name should be used. E.g.,
Vitamin C / Ascorbic acid 500mg; Vitamin A (as Retinyl Ascorbate) 300mcg.
For mineral supplements in the form of a salt, the strength of the element should
be declared. E.g., Ferrous sulfate 50mg (providing 10mg elemental Iron).
“Quantity of active ingredients” refers to the quantity of each active ingredient in
each dosage form or the recommended dose.
Guidelines for Labelling Standards of HS and TM Sep 2023
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 6 of 9
Where there is no dosage unit for dosage forms such as ointments and creams,
the quantity of each active ingredient may be expressed in terms of weight or
volume or as percentage by weight or volume of the total quantity. E.g., Methyl
salicylate 9g per 30g or 30% (w/w), Menthol 10mL per 100mL or 10% (v/v),
Camphor 1g per 25g or 4% (w/w).
4. Intended Purpose
“Intended Purpose” refers to a statement in relation to a product’s indications,
benefits, or actions. The statement of the intended purpose or intention of use
should be declared according to the Guidelines for Claims and Claims
Substantiation of Health Supplements and Traditional Medicines.
5. Dosage and Directions of Use
The recommended dosage and directions of use provide information on the route
of administration, dose, frequency, and duration of use (where applicable) for
which the product is intended for use.
6. Batch Number or Lot Number
“Batch Number” or “Lot Number” refers to a designation (in numbers, or letters,
or combination of both) that identifies the product batch and allows traceability of
the complete history of a specific product batch including all stages of production,
control, distribution, and raw materials used. The Batch Number should be
preceded by a title such as “Batch Number”, “Batch No.” or “BN”.
7. Expiry Date
“Expiry Date” refers to the date assigned for each individual batch before which
the batch still meets the required standard specifications for quality. Expiry date
should be declared in month and year (e.g., Jan/2022, 01/2022) and preceded
by a title such as “Expiry date” or “EXP” to avoid ambiguity and confusion.
8. Country of Manufacture
This refers to the country where the product is manufactured.
9. Name and Address of Local Importer (for overseas manufactured product)
or Product Owner (for locally manufactured product)
This refers to the complete name and address of the local importer or product
owner of the product.
If the distributor is the same as the importer or product owner, the distributor’s
name and address may be printed on the label instead of the importer or product
owner information.
10. Contraindications
The statement declares situations where the product should not be used.
11. Warnings
The statement declares a warning for consumers’ awareness before using the
product. Warnings may include side effects, contraindications, and precautions
as appropriate.
Certain inactive substances that exhibit sensitising effects are required to be
declared:
Guidelines for Labelling Standards of HS and TM Sep 2023
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 7 of 9
• Benzoic acid
• Sodium benzoate
• Tartrazine
Dealers are encouraged to review the safety of other sensitising agents that may
be present in their products and declare their presence on the product label
where necessary.
TM making claims on symptomatic relief for non-serious medical conditions
would be required to include the statement “If symptoms persist, talk to your
healthcare professional”, to ensure that consumers do not delay in seeking
appropriate treatment should their symptoms persist.
12. Storage Condition
The statement declares a condition to which the product should be stored
properly to maintain the quality of the product throughout its declared shelf life.
13. Pack Size or Net Content
Pack size or net content refers to the amount of the product in a pack or container.
This can be presented in absolute quantity (for solid dosage form) e.g., 30
capsules/container or net content (for liquid, powder, or semi-solid dosage
forms), e.g., 500mL/bottle.
Guidelines for Labelling Standards of HS and TM Sep 2023
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 8 of 9
Revision History
Version
Date of
publication
Summary of changes*
1
March 2022
New document
2
July 2022
Added Table 2 Examples of Naming of Active
Ingredients.
3
July 2023
• Included medicated oils, balms and medicated
plasters
• Included a paragraph to clarify on how the
quantity of a topical preparation is to be declared.
4
September 2023
Included clarification on labelling requirement on the
name and address of local dealer for products
manufactured in Singapore.
*Editorial changes are not reflected
Guidelines for Labelling Standards of HS and TM Sep 2023
HEALTH SCIENCES AUTHORITY – HEALTH PRODUCTS REGULATION GROUP Page 9 of 9
Contact information
Complementary Health Products Branch
Medicinal Products Pre-Market Cluster
Health Products Regulation Group
Health Sciences Authority
11 Biopolis Way
Singapore 138667
www.hsa.gov.sg
Email: [email protected]
