RegulatoryOfficial

AEMPS orders withdrawal of Daen men's depilatory cream over unsafe usage instructions

🇪🇸 AEMPS · Thu 22 Oct 2026

Spain's medicines agency says the labelling allowed several large body areas to be treated in one day, exceeding the exposure assumed in the safety assessment; the product is back on sale with a new warning.

The Spanish Agency for Medicines and Health Products (AEMPS) has announced that all batches of Daen Crema Depilatoria for Men have been withdrawn from the market and their sale discontinued. The notice, published on 21 October 2026 under reference COS 21/2026, says the measures were ordered because the instructions for use could not ensure safe conditions of use.

According to the agency, the directions allowed the cream to be applied to several extensive areas of the body on the same day. That could lead to excessive exposure and a health risk for users. AEMPS stresses that the problem is not linked to the product's composition but to the usage conditions described on the label, which allowed higher exposure than the one considered in the safety assessment.

The action followed a review of the product's safety report, as part of a campaign checking cosmetic safety assessments that AEMPS began in 2025. The regional health authorities have been informed. The responsible person for the cosmetic, Laboratorios Ibercosmetic, S.L., has stopped marketing and withdrawn the product.

The company has since amended the instructions to add a warning on which body areas may be depilated in a single day. The updated label advises against treating more than one large area, such as chest, back, arms or entire legs, on the same day, and recommends waiting at least a week between depilations of the same area. Units currently on sale carry this warning, and marketing has resumed with the revised labelling.

Consumers who already own the product may keep using it, provided they follow the same two conditions: no more than one large body area per day, and at least one week between treatments of the same area. AEMPS asks anyone aware of an incident linked to a cosmetic to report it through its NotificaCS portal.

What it means for your team

  • Under EU cosmetics rules, the responsible person must ensure that the safety assessment reflects the use conditions stated on the label; this case shows regulators checking that the two match.
  • The AEMPS campaign on safety assessments, running since 2025, may lead to further label or marketing actions on other cosmetics.
  • Teams handling depilatory or similar rinse-off and leave-on products should review whether the exposure scenarios in their safety reports cover the maximum use the instructions allow.
  • Cosmetovigilance teams should note that undesirable effects can be reported through NotificaCS, which AEMPS describes as essential to its oversight.

Official source: AEMPS ↗

Article written by VigiEye from the official source (AEMPS). AI-assisted; check the source before acting.

More Regulatory All →