(9) The manufacture and expiration dates.
(10) The storage conditions.
(11) Dosage, route and frequency of administration.
(12) Indication for the product.
Labelling of bulk package
10. Where a herbal medicine or related product is sold in bulk for further manufacturing, provisions of this
regulation shall not apply, provided that, the label of the bulk product contains the following information:
(1) The proprietary or brand name of the herbal medicines.
(2) The botanical or common name of the herbal medicines.
(3) A statement of net contents.
(4) An identifying lot or batch number.
(5) The manufacture and expiration dates.
(6) Statement of caution e.g. "manufacturing purpose only".
Labelling Information for Practitioners
11. All herbal medicines or related products may be accompanied by an outer label and package insert with
relevant information to practitioners for the safe use of the products.
Adequate Information on the insert
12.(1) Relevant information required to appear on the package insert for Practitioners shall include:
(a) Description;
(b) Clinical Pharmacology;
(c) Indications and usage;
(d) Contraindications;
(e) Warnings against misuse;
(f) Precautions;
(g) Dosage and administration;
(h) Adverse reactions;
(i) Drug abuse and dependence;
(j) Symptoms of over dosage and antidote;
(k) How supplied;
(l) Animal Pharmacology and/or Animal;
(m) Toxicology;