SOLUPREP ANTISEPTIC SWAB large (clear) medicated swab, 3M Australia Pty Ltd, CON-1074
Product name
SOLUPREP ANTISEPTIC SWAB large (clear) medicated swab
Sponsor name
3M Australia Pty Ltd
Consent start
Consent no.
CON-1074
Standard
paragraph 8(1)(k) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines
Non-compliance with standard
The 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 statement 'Seek immediate
medical assistance if this occurs' and instead state 'Stop use if this occurs'.
They also do not include the specific statement 'Mild skin irritation may occur;
stop use if it becomes more severe.' but instead state 'Discontinue use if
irritation and redness develops'.
Therapeutic product type
Over-the-counter medicines