CAROTONE skin-brightening products found to contain undeclared prescription-only medicine

The Therapeutic Goods Administration (TGA) advises consumers that CAROTONE products marketed for skin brightening may pose a serious risk to your health and should not be used.

The TGA has tested the following imported unapproved products and found that they contain undeclared hydroquinone at concentrations of 3.6%, 2.9% and 3.4%.:

• CAROTONE Brightening Oil 65mL
• CAROTONE Clarifying Cream 300mL
• CAROTONE Brightening Body Lotion 350mL

Hydroquinone is generally used in skin lightening products and to treat conditions associated with hyperpigmentation.

In Australia, products containing more than 2% hydroquinone are prescription-only medicines. They should only be used if prescribed by a health professional.

Hydroquinone can cause serious side effects, especially if used without medical advice.

The products tested by the TGA are considered counterfeit under the Therapeutic Goods Act 1989.

Counterfeit products cannot be imported under the Personal Importation Scheme. Knowingly importing, supplying and/or giving away counterfeit therapeutic goods is illegal and poses a significant public health and safety risk.

We urge consumers to exercise extreme caution when buying medicines and medical devices online. These products may:

• be fake
• may contain undeclared and potentially harmful ingredients
• may not meet the same standards of quality, safety and efficacy as those approved by us for supply in Australia.

For your safety, always buy medicines and medical devices from reputable sources and consult your healthcare provider or local registered pharmacy if you have any concerns.

In 2021, the TGA published a safety alert after testing similar Carotone branded products with over 2% concentration of hydroquinone, considered counterfeit.

Information for consumers

• Stop using CAROTONE Brightening Oil, CAROTONE Clarifying Cream and CAROTONE Brightening Body Lotion and take any remaining products to your local pharmacy for safe disposal.
• If you have any concerns arising from your use of these products, consult your health care practitioner.
• If you suspect you have had a side effect (also known as an adverse event) to these products or similar medicines, report it to the TGA.

Action we are taking

We are working with the Australian Border Force (ABF) to help stop future shipments of CAROTONE Brightening Oil, CAROTONE Clarifying Cream and CAROTONE Brightening Body Lotionfrom entering Australia.

We will notify ABF to seize and destroy any of these products intercepted at the border.

Report counterfeit medicines and medical devices

If you are worried about counterfeit medicines or medical devices, and want to report an issue, you can report the matter to the TGA:

Product photos

CAROTONE Brightening Oil 65 mL
CAROTONE Clarifying Cream 300 mL
CAROTONE Brightening Body Lotion 350 mL