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Aloe Medicated Skin Cream (Pro Ma Systems Aust Pty Ltd)

Product Name
Aloe Medicated Skin Cream
ARTG
119034
Date of review outcome
Date of publication
Sep-2023
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?
Do not use this medicine because it is past its expiry date
Review scope
Targeted (See Additional Information below)
Information reviewed
ARTG Record
Issues related to safety
This medicine contains HICC (4-(4-hydroxy-4-methylpentyl)-3-cyclohexene carboxaldehyde), which is an ingredient that is not permitted for use in listed medicines. It may cause skin sensitisation, including redness and allergic dermatitis.
However, the last batch of this medicine expired in July 2023 and there is no stock on the market. Therefore, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The efficacy of this medicine was not assessed as part of this review
Actions taken during the review
The TGA required the sponsor to correct the issues with this medicine. The sponsor cancelled this medicine and withdrew it from further supply.
Additional information
This medicine was targeted to check the presence of HICC in the product

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