AVAGARD ANTISEPTIC SURGICAL HAND SCRUB chlorhexidine gluconate 4% w/w solution bottle, 3M Australia Pty Ltd, CON-1116
Product name
AVAGARD ANTISEPTIC SURGICAL HAND SCRUB chlorhexidine gluconate 4% w/w solution bottle
Sponsor name
3M Australia Pty Ltd
Consent start
Consent no.
CON-1116
Standard
paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines
Non-compliance with standard
The carton labels do not include certain required warning statements specified
in the Therapeutic Goods (Medicines Advisory Statements) Specification 2021
(RASML No. 6). Specifically, the labels do not include the statements 'Seek
immediate medical assistance if this occurs' and 'Mild skin irritation may
occur; stop use if it becomes more severe.' and instead state 'Severe allergic
reactions can occur. Stop use if this occurs'.
Therapeutic product type
Over-the-counter medicines