Antiseptic Soothing Cream

What is Antiseptic Soothing Cream®?

Antiseptic Soothing Cream is used for the treatment of insect bites, stings and itches, and minor burns and sunburn. It can be bought from a pharmacy, supermarket or dairy.

What are the safety concerns?

Antiseptic Soothing Cream contains the ingredients bufexamac, chlorhexidine gluconate and lidocaine hydrochloride.

Serious skin reactions have been reported overseas following the use of bufexamac-containing products. The Australian Therapeutic Goods Administration (TGA) removed bufexamac-containing products from the Australian Register of Therapeutic Goods on 18 September 2020. The TGA determined that the benefit-risk balance of bufexamac-containing products is unacceptable due to a risk of serious skin reactions and inadequate evidence that bufexamac is effective.

Due to the serious nature of the actions taken in Australia, Medsafe has decided to conduct a benefit-risk review for bufexamac-containing products. As a result Medsafe has issued a notice requesting the manufacturer/sponsor provide evidence of the safety and efficacy of Antiseptic Soothing Cream.

What should you do?

If you have used this product and feel unwell or have had a reaction, seek medical advice. Tell your healthcare provider that you have used Antiseptic Soothing Cream and they or you can report the side effect to CARM.

Reference

  1. Antiseptic Soothing Cream: review of the benefits and risks requested under section 36 of the Medicines Act 1981 Medsafe, NZ, December 2020