Cerumen, otherwise known as earwax, is produced by glands and made of oil from the skin, dead skin cells, sweat, and dirt1.  It protects the ear by moistening the ear canal and helping to prevent infections1.  It is normally secreted in small amounts and moves out of the ear when you talk and chew, and through movement of the hair cells in the ears1.  However, many things can disrupt the normal outward movement to the outer ear, resulting in the buildup of earwax.

One of the reasons that wax can accumulate is due to the number of glands in the ear which decreases as you become older. This results in the production of earwax that is drier and harder to remove naturally from the canal1,2.  Earwax buildup can also occur from use of hearing aids, earplugs, cotton-tipped applicators, or even bony growths in the canal2.  Overtime, earwax buildup can lead to hearing loss, sensation of fullness in the ear, and discomfort1.  It is one of the most common ear-related problems that require care from general practitioners3.

Cerumol® is a popular and commonly used ear drop that is marketed to relieve earwax impaction.  Since this product has been on the market for over 50 years, we wanted to take a look at the evidence behind its safety and effectiveness.

What is it?

Cerumol® is an oil-based ear drop that loosens and lubricates blocked earwax to ease its removal.  It is classified as a “cerumenolytic” – something that breaks down earwax3.  Cerumol® has four main ingredients: chlorbutol (5%), paradichlorobenzene (2%), oil of turpentine (10%) and arachis oil (peanut oil) (57.3%).

How does it work?

When an earwax block occurs, there are many ways to remove the earwax.  It is generally discouraged to remove the earwax yourself, especially with cotton-tipped applicators because it can actually push the earwax further into the canal and worsen the condition1,3.  There are a number of eardrops that can help remove earwax.

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Water-based products tend to work as cerumenolytic agents by hydrating the wax which causes breakdown of the keratin and then the wax4.  Although Cerumol® is classified as a cerumenolytic, oil-based products are not “true cerumenolytics” because they only soften and lubricate the wax, so there is no actual breakdown of the cerumen3.  The peanut oil and oil of turpentine in Cerumol® are lubricating agents.  The chlorobutanol is an antibacterial and antifungal, and helps reduce the thickness of the oils to better penetrate earwax.  The paradichlorobenzene is an insecticide and also acts to reduce the thickness5.

What does the evidence say?

A limited number of studies have compared how effective different cerumenolytics work either alone or in combination with water irrigation to remove earwax.  However, the downside is that most of these studies have been fairly small and of poor quality2,4.  Most of the studies have concluded that there is no eardrop that is any better than another; however, most studies have agreed that using either a water or oil-based drop is more effective than using nothing at all2,3,4.  In fact, most have found that using body-temperature water or saline is just as effective as any of the commercially-made eardrops2,3,4.  Cerumol® has been compared to various other agents including sodium bicarbonate (a water-based drop), Audax® (non- water, non-oil), Auro® (water-based), olive oil and Exterol® (hydrogen peroxide drops).  All cases have found either no difference between the drops, or that Cerumol® was actually slightly less effective in loosening and reducing impacted earwax1,2,3,4,6.  A few individual studies have found weak evidence slightly in favour of one eardrop over another4,6.  Water-based and oil-based drops either used on their own or used prior to water irrigation werefound to be equally effective in most studies2,3,4.

Overall, we would need more high quality studies to be able to narrow down a recommendation to just one product.  For now, any cerumenolytic seems to be just as good as the next at reducing impacted earwax.

How safe is Cerumol® ?

Cerumol® is generally well-tolerated, with only mild possible side effects of redness, irritation or rash, although these have not been mentioned in studies1,2.  Usage may cause temporary deafness, and drops that are too cold may cause dizziness2.  However, this product should not be used if the patient is also experiencing otitis externa (swimmer’s ear), seborrhea (a scaly rash), eczema of the outer ear, or has a perforated eardrum1.  No side effects have been reported in pregnancy or lactation 2.

If accidentally ingested, most ingredients are in concentrations too low to cause toxicity2.  Patients who have allergies to peanuts, soya, or any of the ingredients should not use Cerumol®.

What about ear candling?

Studies have shown that the alternative method of “ear candling” does not actually create a vacuum over the ear canal and thus removes no wax from the ear.  Any wax found on the candle is only wax that has burned off the candle, and not from the ear.  On several occasions, ear candling has led to severe burns of the face and ear, worsened earwax occlusion and even broken eardrums3.

Bottom Line

Studies have shown that using Cerumol® is not superior over other water or oil based cerumenolytics, and none were any better than either saline or water.  Using Cerumol® has been shown to improve the process of irrigation of the ear, but is not advantageous over any other agents.  Considering its reasonable price-point, if you’ve tried home remedies such as olive oil or saline with no success, Cerumol® may be worth a shot.

 

Authors:

Ema Allemano, Jenna Buxton, Bingjie Jin, Chen-En Ma, & Binh Nguyen, B.Sc. Pharm Candidate(s)

Faculty of Pharmacy & Pharmaceutical Sciences

University of Alberta

Edited and Reviewed by The Health Aisle Team

References

  1.  Shevchuk, Yvonne M. (2013). Impacted Earwax. Therapeutic Choices for Minor Ailments: Pg. 166-169.
  2.  Burton MJ, Doree C (2009). Eardrops for the removal of earwax (review). The Cochrane Collaboration. Issue 1: 1 – 33. DOI: 10.1002/14651858.CD004326.pub2
  3. Roland P. et al (2008). Clinical practice guideline: Cerumen impaction. Otolaryngology: Head and Neck Surgery. 139(3S2): DOI: 10.1016/j.otohns.2008.06.026
  4. Hand C, Harvey I (2004). The effectiveness of topical preparations for the treatment of earwax: systematic review. British Journal of General Practice. 54: 862-867.
  5. Cerumol ear drops. (2013, October 23). Retrieved from http://www.medicines.org.uk/emc/medicine/25285/SPC/Cerumol Ear Drops/
  6. Oron Y. et al (2011). Cerumen removal: Comparison of cerumenolytic agents and effect on cognition among the elderly. Archives of Gerontology and Geriatrics. 52: 228-232.