PAINRELIEV COOLING PATCH (Shen Neng Herbal Medicines Group Pty Ltd)
Product Name
PAINRELIEV COOLING PATCH
ARTG
99917
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?
Do not use this medicine if you are pregnant or likely to become pregnant, and do not administer this medicine to children under the age of 18 years. Seek advice from a suitably qualified health practitioner if you have been doing so.
This medicine contains methyl salicylate, menthol and sesame seed products. Consider whether the medicine is right for you if you have allergies or sensitives 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. Be aware that application of this medicine to the skin may increase sensitivity to sunlight; avoid prolonged exposure to the sun. If irritation develops, discontinue use and consult a suitably qualified health practitioner.
This medicine contains methyl salicylate, menthol and sesame seed products. Consider whether the medicine is right for you if you have allergies or sensitives 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. Be aware that application of this medicine to the skin may increase sensitivity to sunlight; avoid prolonged exposure to the sun. 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 medicine contains herbal ingredients (Aconitum carmichaelii and Aconitum kusnezoffi) in a combined amount which is only allowed for use in listed medicines in adults. However, the label of the medicine lacked a warning statement that the medicine should only be used in adults. These restrictions are in place to ensure the safe use of listed medicines. However, current data indicates that the amount of Aconitum carmichaelii and Aconitum kusnezoffi in the medicine are unlikely to pose an immediate safety risk to children.
Additionally, the label did not include the warning statements ‘adults only’, ‘contains methyl salicylate’, ‘do not use if pregnant or likely to become pregnant’, ‘application to skin may increase sensitivity to sunlight’, ‘avoid prolonged exposure in the sun’, ‘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 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.
Additionally, the label did not include the warning statements ‘adults only’, ‘contains methyl salicylate’, ‘do not use if pregnant or likely to become pregnant’, ‘application to skin may increase sensitivity to sunlight’, ‘avoid prolonged exposure in the sun’, ‘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 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.