Premium Eczema Cream (Body and Soul Health Products Pty Ltd)
Product Name
Premium Eczema Cream
ARTG
264355
Date of review outcome
Date of publication
Dec-2024
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, follow the recommended actions below.
What action should consumers take?
This medicine contains benzoates, sorbates, and phenoxyethanol. Consider whether it is right for you if you have allergies or sensitivities to these substances. If you develop a reaction, discontinue use and consult a suitably qualified health professional.
Seek advice from a suitably qualified health professional if you have been using this medicine to treat eczema or psoriasis.
Seek advice from a suitably qualified health professional if you have been using this medicine to treat eczema or psoriasis.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
This medicine contains benzoates, sorbates, and phenoxyethanol, which were not declared on the website for this medicine. Benzoates, sorbates, and phenoxyethanol are required to be declared on the labels and in the advertising of medicines that contain them, as they may cause adverse reactions in individuals with allergies or sensitivities to this group of substances. However, the label for this medicine includes the statement 'includes potassium sorbate and preserved using benzyl alcohol and phenoxyethanol', which alerts consumers to the presence of these substances in this medicine.
The label and website for this medicine contained claims relating to eczema and psoriasis. Eczema and psoriasis can be serious conditions that require diagnosis, treatment or supervision by a suitably qualified health professional. References to eczema or psoriasis without specifying mild forms of the condition is not permitted for medicines that are available for self-selection without prior evaluation by the TGA. The reference to eczema or psoriasis has the potential to lead consumers with eczema or psoriasis to delay access to timely medical advice or treatment resulting in adverse outcomes. However, the label and website also warns consumers to see a healthcare practitioner if symptoms persist.
As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
The label and website for this medicine contained claims relating to eczema and psoriasis. Eczema and psoriasis can be serious conditions that require diagnosis, treatment or supervision by a suitably qualified health professional. References to eczema or psoriasis without specifying mild forms of the condition is not permitted for medicines that are available for self-selection without prior evaluation by the TGA. The reference to eczema or psoriasis has the potential to lead consumers with eczema or psoriasis to delay access to timely medical advice or treatment resulting in adverse outcomes. However, the label and website also warns consumers to see a healthcare practitioner if symptoms persist.
As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The label and website for this medicine contained claims relating to eczema and psoriasis. However, these claims were not covered by the sponsors certification that they held evidence to substantiate them.
Actions taken during the review
The sponsor cancelled this medicine, withdrew it from further supply and removed the advertisement from their website. Nevertheless, the TGA issued an educational letter to the sponsor outlining the issues with this medicine.