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Consultation: Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Lidocaine (lignocaine)

6 April 2021

This consultation closed on 18 May 2021.

The Therapeutic Goods Administration (TGA) sought comments from interested parties on addition of a proposed new required advisory statement for labels of non-prescription medicines containing more than 1.5 per cent lidocaine (lignocaine) for topical oral use, for inclusion in the Required Advisory Statements for Medicine Labels (RASML) document.

The required advisory statement "Do not use for teething pain in children" is proposed for preparations for topical oral use containing 1.5 per cent or more of lidocaine, to ensure that consumers and health professionals are aware that these medicines are not suitable for use for teething in children.

For more information and to participate in the consultation, please visit consultation hub.

Timetable

The consultation opened on Tuesday 6 April 2021. Interested parties responded by close of business, Tuesday 18 May 2021.

Enquiries

Any questions relating to submissions should be emailed to rasml@health.gov.au.