Topical corticosteroids: Proposal for the package labelling to state their potency

Overview

Medsafe is seeking your feedback on a proposed advisory statement for topical corticosteroids to include information about the potency (strength) on the container/package label.

In March 2025, the Medicines Adverse Reactions Committee (MARC) reviewed the risk of topical steroid withdrawal reactions. The MARC commented that inappropriate overuse of topical corticosteroids is common and noted the recent action taken by the United Kingdom’s medicines regulator, the Medicines and Healthcare products Regulatory Agency, to have topical corticosteroid products labelled with information on their potency. The MARC considered that having potency information on New Zealand labels would be helpful for consumers.

Topical corticosteroids are medicines that are applied to the skin to treat various inflammatory skin conditions, such as eczema, dermatitis and psoriasis. They are available in different potencies (strengths): mild, moderate, potent or very potent. Because topical steroids are absorbed through the skin, they can occasionally cause serious side effects, such as adrenal suppression or Cushing’s syndrome. These serious side effects are related to the amount, potency and duration of use of the corticosteroid.

Topical corticosteroid products with only one active ingredient are known as ‘plain’ topical corticosteroids. Some topical corticosteroid products may also include another active ingredient such as an antifungal, antibiotic, antiviral or calcipotriol. These are known as ‘combination’ products. There are more than 50 approved topical corticosteroid products in New Zealand.

Depending on the condition being treated, patients may be prescribed multiple topical corticosteroid products. The products may have different potencies and be used on different areas of the skin for a specified period of time. Some mild potency topical corticosteroids are also available without a prescription.

Having the potency stated on the package labelling has benefits for consumers, including the following. 

• Clearer labelling, making it easier for consumers to recognise that the product is a topical corticosteroid. This is important when different products for the skin are being prescribed (eg, moisturisers and soap substitutes).
• For consumers who are prescribed multiple topical corticosteroids with different potencies, labelling may prevent accidental use of stronger corticosteroids on more delicate areas of the body.  
• Enhance consumer knowledge and encourage engagement in the management of their skin condition.

The New Zealand Formulary uses the following classification system to describe and group the potency of topical corticosteroids. We propose using the same classification system.

• Mild: hydrocortisone
• Moderate: clobetasone and triamcinolone acetonide
• Potent: betamethasone valerate, betamethasone dipropionate, hydrocortisone butyrate, mometasone furoate, and methylprednisolone aceponate
• Very potent: clobetasol propionate and betamethasone dipropionate (in an optimised vehicle).

The Label Statements Database lists the warning and advisory statements that are required on the package labelling for medicines and related products. Currently, there are statements for hydrocortisone, clobetasone and aclometasone, but they are not about the potency of the corticosteroid.    

Table 1 outlines the proposed advisory statement for topical corticosteroids.  

Table 1: Proposed advisory statement for topical corticosteroids

Medsafe is seeking your feedback on:

• whether the packaging for topical corticosteroids should have an advisory statement about potency
• the conditions that apply to the label statement
• the required by (implementation) date (see Table 1)
• the terms that should be used to describe the potency and the grouping of the different corticosteroids.

Note that it is generally acceptable that words of a similar meaning can be used for statements in the Label Statements Database, provided the intent is not changed. However, to be consistent across products, the specific terms used to describe the various corticosteroid potencies must be used. 

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