The international expansion of our otology product line has reached a milestone of excellence: the completion of the registration of the Borox Ear Spray in the United Arab Emirates. This achievement, coordinated through our partners in Dubai, confirms full product compliance with the rigorous quality and safety standards required by the local Ministry of Health (MoHAP).
Innovation and Protection with Borox Ear Spray
The clinical positioning of Borox Ear Spray identifies it as a multi-action solution for hygiene, protection and prevention of the external auditory canal. The product is particularly indicated for:
- Subjects exposed to humidity: Swimmers, water sports practitioners or those living in tropical climates.
- Prevention of external otitis: Reduction of the risk of recurrent infections through acidification of the ear environment.
- Daily hygiene: Subjects prone to earwax plug formation or who use hearing aids and in-ear headphones.
Formulation and Active Ingredients
The device formula acts on three synergistic fronts through:
- Boric Acid (3%): Thanks to its natural acidifying and antiseptic properties, it limits bacterial and fungal proliferation, maintaining the ear pH at 3.5.
- Sodium Docusate: A premium amphipathic surfactant that emulsifies and fragments excess earwax, facilitating its natural expulsion without mechanical trauma.
- Lactic Acid: Works in combination with boric acid to rebalance the protective hydrolipidic film of the canal.
- Soothing Complex (Glycerin and Chamomile): The hydroglycerine base ensures deep hydration, reducing itching and desquamation of sensitive skin.
Available Formats for Every Need
Within our range of medical devices, the product has been developed in two versions:
- Ear spray (50 ml): With a calibrated dispenser for deep and uniform cleansing.
- Ear drops (10 ml): Ideal for precise dosing in paediatric use.
Advantages of International Registration in the UAE
The fact that the Borox Ear Spray is already registered in the United Arab Emirates represents a strategic asset of great value, enabling our partners to:
- Accelerate commercial access to local distribution channels and pharmacies.
- Avoid bureaucratic delays and lengthy ministerial authorisation procedures.
- Work with an already compliant partner meeting the safety and quality standards required in target markets.
- Leverage Internal Know-how: Being already present in the UAE means we possess the regulatory expertise to support you at every stage of registration, ensuring a direct competitive advantage in commercial planning and return on investment.
As certified manufacturers, we believe in transparency and tangible quality. We offer Borox Ear Spray ready-to-market, compliant with ISO 13485 standards, and also available in private label for our global partners.
Our goal is to make entry into international markets simple, safe and fully documented.
