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Submissions received: Benzocaine: proposed advisory statements for medicines

14 January 2019

The TGA would like to thank the respondent who submitted written comments in response to the consultation: benzocaine: proposed advisory statements for medicines.

Submissions received

One submission was received, with consent provided for publication on the TGA website:

The respondent supported the new warning statement.

Final proposal

Note

New text is shown as green, larger font, with a horizontal line above it.

Advisory statements for benzocaine

A new advisory statement, as originally proposed and as shown below, will be included in the Required Advisory Statements for Medicine Labels (RASML) document when it is next updated (NB: the proposed date of effect for these changes is 1 September 2020).

Column 1
Substance(s)
Column 2
Conditions
Column 3
Required statement(s)
Benzocaine
(Entry 1 of 4)
In dermal preparations containing MORE than 2 per cent of total local anaesthetic substances
  • Do not apply to large areas of the body, except on the advice of a healthcare practitioner.
  • If skin irritation occurs, discontinue use and seek advice from your doctor or pharmacist.
Benzocaine
(Entry 2 of 4)
In dermal preparations containing 2 per cent OR LESS of total local anaesthetic substances
  • If skin irritation occurs, discontinue use and seek advice from your doctor or pharmacist.
Benzocaine
(Entry 3 of 4)
In lozenges
  • Do not take hot food or drink if the mouth feels numb after taking this product as it may burn the mouth.
  • Do not give to children under 6 years of age, unless recommended by a doctor, pharmacist or dentist.

Benzocaine
(Entry 4 of 4)

In preparations for topical oral use EXCEPT lozenges

  • Do not give to children under 2 years of age