COOLING PATCH FOR EXTERNAL PAIN RELIEF (Shen Neng Herbal Medicines Group Pty Ltd)
Product Name
COOLING PATCH FOR EXTERNAL PAIN RELIEF
ARTG
99743
Date of review outcome
Date of publication
Sep-20
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, however use of the medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
This medicine contains menthol, sesame seeds and tree nut products. Consider whether the medicine is right for you if you have allergies or sensitivities to these substances. Avoid contact with eyes, and test this product on a small area of skin before applying it to a large area if you have sensitive skin. If irritation develops, discontinue use and consult a suitably qualified health practitioner.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels, Laboratory Results, Manufacturing Documentation
Issues related to safety
The label did not include the warning statements ‘avoid contact with eyes’, ‘if you have sensitive skin, test this product on a small area of skin before applying it to a large area’, ‘if irritation develops, discontinue use’ and ‘contains sesame seed and tree nut products’. These warning statements are necessary to ensure the safe use of the medicine and to alert consumers to safety risks prior to taking the medicine. However, current data indicates that the absence of these warning statements is unlikely to pose an immediate risk to consumers.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
The TGA required the sponsor to correct the issues with their medicine. The sponsor cancelled the medicine and withdrew it from further supply.
Additional information
This medicine was targeted to check its compliance with quantity and labelling requirements related to the ingredient Aconitum spp.