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Cerumenolytic Pregnancy: §4.6 quoted in full: 'No known side effects.' The fetched SPC provides no further pregnancy, breastfeeding or fertility data, and assigns no pregnancy category letter.

Urea hydrogen peroxide

Brand names: Otex, Earex

Urea hydrogen peroxide ear drops are a cerumenolytic used to soften and help disperse ear wax in the external ear canal.

Adult dose

Dose: Softening and removal of ear wax (cerumenolysis) — instil up to 5 drops into the affected ear. §4.2 quoted in full: 'For adults, children and the elderly: Instill up to 5 drops into the ear. Retain drops in ear for several minutes by keeping the head tilted and then wipe away any surplus. Repeat once or twice daily for at least 3 to 4 days, or as required.'
Route: Topical, instilled into the ear (otic). §4.4 verbatim: 'Keep Otex away from the eyes. For external use only.' §4.5 verbatim: 'Otex should not be used at the same time as anything else in the ear.'
Frequency: Once or twice daily for at least 3 to 4 days, or as required.
Max: 5 drops per instillation, given at most twice daily — the SPC's stated ceiling is 'up to 5 drops' per instillation, repeated 'once or twice daily'.
SCOPE — this record covers Otex Ear Drops, one of the two brands this page names. The page's other named brand, Earex, is a separate product with its own SPC which is NOT in this bundle; its strength and regimen are not covered here. That is no longer true — Otex Ear Drops is a licensed UK product with the SPC above, it is a brand this page itself names, and it is a cerumenolytic ear drop, matching this page's category and route exactly. Three-times-daily dosing does NOT appear anywhere in this SPC — the label says 'once or twice daily' — so TDS has not been carried forward. TIMING RESTRICTION, §4.3 verbatim: 'it is inadvisable to use Otex within 2 to 3 days of syringing.'

Paediatric dose

Route: Topical (otic) — instilled into the ear
Frequency: Once or twice daily for at least 3 to 4 days, or as required
Max: 5 drops per instillation, at most twice daily
The SPC gives ONE dose covering every age group and does not separate a paediatric regimen. §4.2 verbatim: 'For adults, children and the elderly: Instill up to 5 drops into the ear.' The dose is therefore identical to the adult dose and is NOT weight-based, so dosePerKg is deliberately null and the weight calculator is left unset. No minimum age and no paediatric restriction is stated anywhere in the fetched SPC. The §4.3 contraindications — in particular known or suspected eardrum damage, and prior mechanical attempts to dislodge wax — apply to children as written.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • §4.3 verbatim: 'Do not use if the eardrum is known or suspected to be damaged, in cases of dizziness, or if there is, or has been, any other ear disorder (such as pain, discharge, inflammation, infection or tinnitus).'
  • §4.3 verbatim: 'Do not use after ill-advised attempts to dislodge wax using fingernails, cotton buds or similar implements, as such mechanical efforts can cause the ear's delicate inner lining to become damaged, inflamed or infected, whereupon the use of ear drops can be painful.'
  • §4.3 verbatim: 'For similar reasons, it is inadvisable to use Otex within 2 to 3 days of syringing.'
  • §4.3 verbatim: 'Do not use where there is a history of ear problems, unless under close medical supervision.'
  • §4.3 verbatim: 'Do not use if sensitive to any of the ingredients.'

Side effects

  • §4.8 verbatim: 'Due to the release of oxygen, patients may experience a mild, temporary effervescence in the ear.'
  • §4.8 verbatim: 'Instillation of ear drops can aggravate the painful symptoms of excessive ear wax, including some loss of hearing, dizziness and tinnitus.'
  • §4.8: irritation or pain in the ear — 'Stop usage if irritation or pain occurs.'
  • Very rare, §4.8 verbatim: 'unpleasant taste has been reported.'

Monitoring

  • §4.8 verbatim: 'Stop usage if irritation or pain occurs.'
  • §4.8 verbatim: 'If patients encounter any of these problems, or if their symptoms persist or worsen, they should discontinue treatment and consult a doctor.'
  • §4.3: use only under close medical supervision where there is any history of ear problems; confirm the tympanic membrane is intact before use.

Clinical monograph

How it works

On contact with cerumen it releases oxygen and effervesces, mechanically breaking up and loosening the wax to aid its removal.

Prescribing in practice

  • It should not be used if the eardrum is perforated or if there is ear discharge suggesting infection, without seeking advice first.
  • Transient effervescence, bubbling sensation or mild irritation in the ear is expected during use.
  • It softens wax and does not treat ear infection.

Monitoring

No formal monitoring is required; review if wax-related hearing loss or discomfort persists after a reasonable course.

Counselling the patient

  • You may feel bubbling or fizzing in the ear, which is normal.
  • Do not use if you have a known hole in the eardrum or ear discharge.
  • Avoid cotton buds and seek advice if you develop ear pain.

Evidence & guidelines

Use as a wax-softening agent reflects standard practice consistent with NICE guidance on ear wax management.

Reference: NICE CG98; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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