AVAGARD ANTISEPTIC CHG HAND RUB solution bottle, 3M Australia Pty Ltd, CON-1118
Product name
AVAGARD ANTISEPTIC CHG HAND RUB solution bottle
Sponsor name
3M Australia Pty Ltd
Consent start
Consent no.
CON-1118
Duration
The consent is effective from 16 June 2023 until 1 January 2024.
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”.
Import, Supply, &/or Export
supply
Therapeutic product type
Over-the-counter medicines