其 他 安 全 警 示
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| Australia: Changes to the label warning statement requirements for menthol & methyl salicylate (English only) |
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Therapeutic Goods Administration (TGA) announces that it will amend the current requirements to be less restrictive for menthol, methyl salicylate and related ingredients as outlined below after reviewing the previous safety evaluations and taking into account new information.
The following warning statements will only be required on the label of topical listed medicines of menthol and ingredients containing menthol when the concentration of menthol in the medicine is greater than 1%:
- (IRRIT) 'If irritation develops, discontinue use' and
- (SKTEST) 'If you have sensitive skin, test this product on a small area of skin before applying it to a large area'.
The changes to the requirements for menthol will be introduced for the following ingredients: Mentha aquatic, Mentha arvensis, Mentha arvensis leaf oil, Mentha arvensis oil, Mentha haplocalyx, Mentha pulegium, Mentha spicata, Mentha x cardiac, Mentha x piperita, menthol, mint oil dementholised, peppermint american ext., peppermint leaf dry, peppermint leaf powder, peppermint oil, peppermint oil terpeneless, peppermint oil terpenes and terpenoids, spearmint oil, spearmint oil terpeneless.
The following warning statement will only be required on the label of topical listed medicines of methyl salicylate and ingredients containing methyl salicylate when the concentration of methyl salicylate is greater than 1%:
- (IRRIT) 'If irritation develops, discontinue use'.
The changes to the requirements for methyl salicylate will be introduced for the following ingredients: Betula lenta, Betula nigra, Betula pendula, birch leaf dry, Filipendula ulmaria, Gaultheria procumbens, meadowsweet herb dry, methyl salicylate, Nyctanthes arbor-tristis, wintergreen oil.
All other requirements and label warnings for the affected ingredients will remain the same as currently listed in the Determination. The transition periods for compliance with the amendments to both menthol and methyl salicylate will remain the same, as the above amendments are not introducing more restrictive requirement. These changes will be implemented as soon as possible and a new Determination is expected to be in effect by the end of Dec 2019.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/changes-label-warning-statement-requirements-menthol-methyl-salicylate
In Hong Kong, there are registered pharmaceutical products which are topical preparations containing menthol and/or methyl salicylate. So far, the Department of Health (DH) has received four cases of adverse drug reaction in connection with topical preparation containing menthol and/or methyl salicylate, of which one case was related to allergic dermatitis; another case was related to skin injury, skin red, blister, peeling, discomfort. Hypersensitivity reactions including contact dermatitis of menthol and irritation to the skin of methyl salicylate are documented in overseas reputable drug references such as the “Martindale: The Complete Drug Reference”. In Feb 2015, the Registration Committee of the Pharmacy and Poisons Board (Registration Committee) discussed the safety related to methyl salicylate and decided that the sales pack labels and/or package inserts of registered pharmaceutical products containing methyl salicylate for topical administration should include safety information, amongst other things, in relation to allergy to salicylic acid. The DH will remain vigilant on safety update of the drug issued by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/ Tuesday, Dec 3, 2019
Issued at HKT 17:00
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