Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Mylan Products Ltd, Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
The so-called “wax” which often obstructs the external auditory meatus of the ear contains less than 50% of fatty matter derived from secretions of the sebaceous ceruminous glands. The majority of the wax consists of desquamated epithelium, foreign matter and shed hairs. This non-fatty material forms a matrix holding together the granules of fatty matter to form the ceruminous mass.
The addition of oils or solvents binds the mass more firmly together, but aqueous solutions, if they are able to penetrate the matrix, cause a disintegration of the ceruminous mass.
WAXSOL Ear Drops, because of their low surface tension and miscibility, rapidly penetrate the dry matrix of the ceruminous mass, reducing the solid material to a semi-solid debris. This can be syringed away readily, or in less severe or chronic cases, is ejected by normal physiological processes.
There are no available data on systemic absorption following instillation into the ear. However, any absorption which may occur is likely to be of an extremely low magnitude.
Although no toxicity studies via application to the ear are available, oral repeated dose toxicity studies with docusate sodium did not identify any clinically relevant information.
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