Mollenol Sensitive (Jeva Laboratories Pty Ltd)
Product Name
Mollenol Sensitive
Sponsor
ARTG details
Date of review outcome
Date of publication
Sep-2026
Outcome
Medicine continues to be permitted for supply. Batches released from 14 May 2026 must carry a corrected label.
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, use of this medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
Seek advice from a doctor if you are or have been taking this medicine for the treatment of molluscum contagiosum or non-mild forms of eczema, or as a substitute for topical corticosteroids or immunomodulators.
Be aware that this medicine may not work as expected in children in relation to relieving skin dryness, and traditional uses in Western herbal medicine for relieving minor skin eruptions, symptoms of mild eczema/dermatitis, skin inflammation or as a counterirritant, or antimicrobial for minor cuts and abrasions.
Be aware that this medicine may not work as expected in children in relation to relieving skin dryness, and traditional uses in Western herbal medicine for relieving minor skin eruptions, symptoms of mild eczema/dermatitis, skin inflammation or as a counterirritant, or antimicrobial for minor cuts and abrasions.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The labels and website for this medicine contained claims outlined in 'What action should consumers take?' above. Some of these claims are not permitted for listed medicines without prior evaluation or approval from the TGA. The website also contained non-permitted references to sexually transmitted molluscum contagiosum. References to non-permitted claims have the potential to lead consumers to delay access to timely advice or treatment from a suitably qualified health professional, which may result in adverse outcomes. The website also contained claims that topical corticosteroids and immunomodulators may be harmful or ineffectual when used for molluscum contagiosum. These claims are not permitted as they are misleading and have the potential to discourage consumers from seeking necessary medical attention and undertaking treatment prescribed by a medical practitioner.
The website did not display the mandatory warning statement 'Always read the label and follow the directions for use'.
While advertising of this nature and the absence of a warning statement are unacceptable, the claims have been removed from the website and the warning statement has been added. In addition, the website and labels for this medicine advised consumers to consult their healthcare practitioner if symptoms persist, and the affected batches of this medicine expired in January and May 2026. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
The website did not display the mandatory warning statement 'Always read the label and follow the directions for use'.
While advertising of this nature and the absence of a warning statement are unacceptable, the claims have been removed from the website and the warning statement has been added. In addition, the website and labels for this medicine advised consumers to consult their healthcare practitioner if symptoms persist, and the affected batches of this medicine expired in January and May 2026. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The labels and website for this medicine contained claims outlined in 'What action should consumers take?' above. 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 issued a letter to the sponsor outlining the issues with this medicine. The sponsor updated the website and the label to correct the issues.