ARTG Entry
BETADINE
ARTG entry for BETADINE (amylmetacresol, dichlorobenzyl alcohol), ARTG 487551 — Product Information, dosage form, registration history. Compiled by…
- Sponsor: iNova Pharmaceuticals
- Active ingredient: amylmetacresol, dichlorobenzyl alcohol
- Therapeutic area: Infectious Disease
What it is
Betadine is sponsored by iNova Pharmaceuticals . The brand encompasses multiple formulations containing povidone-iodine and related antimicrobial agents, registered for topical and oral use.
Approved indications
Betadine is registered on the Australian Register of Therapeutic Goods in multiple formulations including antiseptic skin preparations, ointments, gargles, paints, creams, liquid sprays, surgical scrubs, solutions, powders, and lozenges .
Regulatory history
Betadine was first listed on the ARTG on 25 October 1991, with initial registrations for Betadine Alcoholic Skin Prep, Antiseptic Ointment, Sore Throat Gargle, Cold Sore Paint Pain Relief Formula, Antiseptic First Aid Cream, Cold Sore Ointment, Antiseptic Liquid Spray, Surgical Scrub, and Antiseptic Solution . Betadine Ready to Use Sore Throat Gargle was registered on 29 November 1994 . Betadine Antiseptic Powder was registered on 6 September 2001 . Betadine Sore Throat Lozenges in three flavours were registered on 21 August 2014 . Betadine Anaesthetic Lozenges in three flavours were registered on 26 April 2017 . Betadine Antiseptic Topical Solution was registered on 11 July 2018 . A combined Betadine Sore Throat Gargle and Anaesthetic Lozenges pack was registered on 8 November 2019 . Betadine Anaesthetic Lozenges with antibacterial and anti-inflammatory properties were registered on 29 August 2024 . Betadine Sore Throat Lozenges were registered on 2 May 2025 .
PBS listing
Betadine Solution 100 mg per mL (10%), 100 mL is listed on the PBS with one item number, unrestricted access, and an ex-manufacturer price of A$12.69 .