Popular teething and mouth ulcer remedy, Bonjela will be pulled from supermarket shelves.
The Therapeutic Goods Administration has changed its categorisation of Bonjela Teething Gel and Bonjela Mouth Ulcer Gel, which means only pharmacies will be able to stock it.
The gels have been reclassified from a Schedule 1 medicine to a Schedule 2 medicine over concerns about toxicity levels.
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Both Woolworths and Coles have already moved to cease stocking the items.
The changes have come after long-held concerns over choline salicylate.
"The therapeutic guidelines in Australia do not recommend teething gels (irrespective of choline salicylate content) because of the lack of evidence of efficacy and the potential for harm," a TGA spokesperson told 9news.com.au.
"Choline salicylate is an ingredient in a number of teething products such as Bonjela Teething Gel. Other products for the relief of pain, inflammation and discomfort associated with mouth ulcers/sores and new dentures or braces also contain choline salicylate.
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"From 1 October 2023, products containing choline salicylate for oromucosal use will be pharmacy medicines (Schedule 2).
"Substances in Schedule 2 may require advice from a pharmacist for safe use, which should be available from a pharmacy or, where a pharmacy service is not available, from a licensed person."
The spokesperson said the change was made in response to an application to amend the Poisons Standard, which was received in July 2021.
Supermarkets will formally stop selling the products from October 1.
