Whitening Triple (Nature's Care Manufacture Pty Limited)
Product Name
Whitening Triple
ARTG
386362
Date of review outcome
Date of publication
Mar-23
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?
Consider whether the medicine is right for you based on it potentially not working as expected in relation to skin whitening
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Manufacturing Documentation
Issues related to safety
The name and the label of the medicine made claims regarding skin whitening, which are not permitted for listed medicines. References to non-permitted claims have the potential to lead consumers to delay access to timely medical advice or treatment when required, and may result in adverse outcomes. However, as the medicine was never supplied in Australia, it is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The name and the label of the medicine made claims regarding skin whitening. However, these claims were not covered by the sponsor's certification that they held evidence to substantiate them.
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor cancelled the medicine and withdrew it from further supply.