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CANESORAL DUO fluconazole 150mg capsule blister pack and clotrimazole 10mg/g cream tube composite pack, Bayer Australia Ltd, CON-889
Product name
CANESORAL DUO fluconazole 150mg capsule blister pack and clotrimazole 10mg/g cream tube composite pack
Sponsor name
Bayer Australia Ltd
Batches
AUD012, AUD013 and AUD014
Consent start
Consent no.
CON-889
Duration
The consent is effective from 6 December 2021 until 31 July 2022.
Standard
Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines
Non-compliance with standard
The product does not fully conform to the requirements of Therapeutic Goods
Order No. 92 – Standard for labels of non-prescription medicines. The tube label
and the inner carton label for clotrimazole cream are not compliant with the
requirements of Therapeutic Goods Order No. 92 – Standard for labels of
non-prescription medicines but are compliant with the requirements of
Therapeutic Goods Order No. 69 – General requirements for labels for medicines.
Conditions imposed
This consent only applies to batches AUD012, AUD013, and AUD014
Import, Supply, &/or Export
Import and supply
Therapeutic product type
Over-the-counter medicines