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POVIDONE-IODINE SOLUTION 10%w/v cutaneous solution ampoule, Bridgewest Perth Pharma Pty Ltd, CON-1390
Product name
POVIDONE-IODINE SOLUTION 10%w/v cutaneous solution ampoule
Sponsor name
Bridgewest Perth Pharma Pty Ltd
Consent start
Consent no.
CON-1390
Duration
The consent is effective from 24 July 2025 until 1 October 2026.
Standard
Paragraphs 8(1)(i), 8(1)(k), 8(1)(l), 8(1)(n), 9(4) and 9(7)(a)(i) of Therapeutic Goods Order No. 92 - Standard for labels of non-prescription medicines
Non-compliance with standard
The product does not conform to the requirements as: - the ampoule label does
not include the contact details of the sponsor or distributor. - the ampoule
label does not include the a required warning statement relating to povidone for
dermal use, 'if skin irritation or rash occurs, discontinue use immediately'. -
the ampoule label does not include the directions for use. - the ampoule label
does not include the complete statement of purpose. - the ampoule label does not
include required text 'do not inject' in a format required, that is, in the same
orientation as main text. - the ampoule label does not include the name and
portion of the active ingredients in the minimum size required for text (not
less than 2.5 millimetres).
Conditions imposed
The ampoule label includes the name of the sponsor and the primary carton
includes the name and contact details of the sponsor.
The primary carton includes the required warning statement (that is missing from
the ampoule) relating to povidone for dermal use, 'if skin irritation or rash
occurs, discontinue use immediately'.
The primary carton includes the complete directions for use and the ampoule
label includes a statement 'topical application'.
The primary carton includes the complete statement of purpose ('a topical
antiseptic for use as a pre-operative skin antiseptic and for the treatment of
minor cuts, abrasions and skin infections') and the ampoule label includes a
modified statement ('antiseptic for topical use').
Import, Supply, &/or Export
supply
Therapeutic product type
Over-the-counter medicines