Proposed warning statement regarding a fire hazard on the labels of paraffin-based skin products

Closed 7 Dec 2018

Opened 26 Oct 2018

Overview

Medsafe is seeking comments on a proposed warning statement regarding a fire hazard on the labels of paraffin-based skin products.

This risk was identified by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK. The MHRA have received reports in which an individual using one or more paraffin-based skin product has died after their clothes and/or bedding caught fire.

The MHRA published a reminder for healthcare professionals in April 2016.

The New Zealand Formulary entry for emollients (ie, non-cosmetic moisturisers in the form of creams, ointments, lotions and gels) contains a safety warning regarding a fire hazard with paraffin-based emollients:

Fire hazard with paraffin-based emollients

Emulsifying ointment or 50% Liquid Paraffin and 50% White Soft Paraffin Ointment in contact with dressings and clothing is easily ignited by a naked flame. The risk is greater when these preparations are applied to large areas of the body, and clothing or dressings become soaked with the ointment. Patients should be told to keep away from fire or flames, and not to smoke when using these preparations. The risk of fire should be considered when using large quantities of any paraffin-based emollient.

Typically only healthcare professionals read the New Zealand Formulary.

Some paraffin-based skin products are classified as general sale or pharmacy-only medicines so it is unlikely a consumer would come into contact with a healthcare professional when buying the product. Also, general sale or pharmacy-only medicines do not always have a data sheet. Without any contact with a healthcare professional, it is unlikely a consumer would be aware that there is a fire hazard with paraffin-based skin products.

The Label Statements Database, published on the Medsafe website, lists the warning and advisory statements that are required on medicines and related product labels. Currently, the Label Statements Database does not have a requirement for a warning statement regarding a fire hazard on the labels of paraffin-based skin products. This means that without any contact with a healthcare professional, a consumer may not be aware of a fire hazard with paraffin-based skin products.

The table below shows two options for the proposed warning statement regarding a fire hazard on the labels of paraffin-based skin products. Words of a similar meaning to each statement may be used.

Medicine/Group/Class

Conditions

Statements or requirements

Required by

Emollient
Includes:

  • Emulsifying wax
  • Liquid paraffin
  • White soft paraffin

For dermal use in products containing 50% or more of paraffin

Option 1

  • Caution: If this product comes into contact with dressings and clothing, the fabric can be more easily ignited with a naked flame. You should keep away from fire when using this product.

Option 2

  • Caution: This product may make dressings and clothing more easily ignited with a naked flame.

31/01/2020

Why We Are Consulting

Medsafe is seeking your comments on:

  1. whether a warning statement is required in the Label Statement Database
  2. the wording of the warning statement
  3. whether a warning statement is required on all products containing emulsifying wax, liquid paraffin or white soft paraffin
  4. whether a warning statement should be used on all pack sizes.

 

What Happens Next

All comments will be considered. Once the analysis of submissions is complete, the guideline document may be revised to include suggested changes.

We will publish the outcome and updated regulatory guideline on the Outcome of Consultations web page on the Medsafe website. To subscribe to an automatic email notification of website updates, please register here.

Audiences

  • Members of the public
  • Health sector
  • Pharmaceutical companies

Interests

  • Therapeutic products
  • Pharmacy