Skip to content
ClinCalc Pro
Menu
Ear Wax Softening / Cerumenolytic Pregnancy: UK SPC §4.6 Fertility, pregnancy and lactation states only: 'No known side effects.' No further pregnancy or lactation data are given in the fetched label.

Urea Hydrogen Peroxide Ear Drops

Brand names: Exterol, Otex, Earex Plus

Urea hydrogen peroxide ear drops are a topical cerumenolytic instilled into the external auditory canal to soften and help disperse impacted ear wax.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Softening and removal of ear wax (cerumenolysis): instil up to 5 drops into the affected ear
Route: Otic (ear drops) — for external use only. 'Retain drops in ear for several minutes by keeping the head tilted and then wipe away any surplus.'
Frequency: Once or twice daily for at least 3 to 4 days, or as required
Max: Maximum 5 drops per instillation, given at most twice daily
VERBATIM UK SPC §4.2: '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.' This §4.2 is COMPLETE in the bundle (no truncation marker) and is the label's only regimen — it applies to adults, children and the elderly alike, so there is no separate adult figure. SOURCE IDENTITY: the fetched product is Otex Ear Drops, which is one of this page's own listed brands (Exterol, Otex, Earex Plus) and matches the page on active class, route (otic) and indication (ear wax). The label's §4.8 corroborates the peroxide mechanism — 'Due to the release of oxygen, patients may experience a mild, temporary effervescence in the ear.' NOT COVERED: the bundle contains only this one brand's SPC. Other urea hydrogen peroxide ear drops on this page (Exterol, Earex Plus) were not fetched; do not assume identical drop counts or courses for a different presentation without checking that product's own SPC. ADMINISTRATION CAUTIONS from §4.4/§4.5: 'Keep Otex away from the eyes. For external use only.' 'Otex should not be used at the same time as anything else in the ear.'

Paediatric dose

Route: Otic (ear drops) — for external use only
Frequency: Once or twice daily for at least 3 to 4 days, or as required
dosePerKg is null deliberately: this is a topical otic preparation with a fixed drop count and NO weight-based dosing — a per-kg calculator must never run on it. The label gives ONE regimen for all ages: VERBATIM §4.2 'For adults, children and the elderly: Instill up to 5 drops into the ear.' No minimum age is stated in the fetched sections, and no separate paediatric figure exists. §4.3 does bear directly on children: do not use if the eardrum is known or suspected to be damaged, or where there is or has been any other ear disorder, and 'Do not use after ill-advised attempts to dislodge wax using fingernails, cotton buds or similar implements.' Verify any under-18 use against a children's formulary.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Do not use if the eardrum is known or suspected to be damaged
  • Cases of dizziness
  • Any other ear disorder, current or past — pain, discharge, inflammation, infection or tinnitus
  • After ill-advised attempts to dislodge wax using fingernails, cotton buds or similar implements — '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'
  • Inadvisable to use within 2 to 3 days of syringing
  • History of ear problems, unless under close medical supervision
  • Sensitivity to any of the ingredients

Side effects

  • Mild, temporary effervescence in the ear, due to the release of oxygen
  • Irritation or pain — stop usage if this occurs
  • Aggravation of the painful symptoms of excessive ear wax, including some loss of hearing, dizziness and tinnitus
  • Unpleasant taste (very rarely reported)

Monitoring

  • §4.8: if irritation or pain occurs, stop using the drops
  • §4.8: 'If patients encounter any of these problems, or if their symptoms persist or worsen, they should discontinue treatment and consult a doctor.'
  • §4.4: 'Keep Otex away from the eyes. For external use only.' Replace the cap after use
  • §4.5: 'Otex should not be used at the same time as anything else in the ear.'

Clinical monograph

How it works

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

Prescribing in practice

  • Do not use when the eardrum is known or suspected to be perforated, or in the presence of acute ear infection or discharge.
  • It is for external-ear (auricular) use only and is intended for short courses to soften wax, sometimes ahead of irrigation.
  • Transient effervescence, a bubbling sensation, mild irritation or temporary dulling of hearing can occur after instillation.

Monitoring

No systemic monitoring is required; review whether the wax has cleared and check for any local irritation or pain.

Counselling the patient

  • You may feel fizzing or bubbling in the ear, which is expected.
  • Lie with the treated ear uppermost for a short time after putting the drops in.
  • Stop and seek advice if you get ear pain, discharge or it does not improve.

Evidence & guidelines

Cerumenolytic ear drops are a standard first-line measure for softening impacted wax, often before irrigation if needed.

Reference: NICE CKS Ear Wax (2022); BSHAA Earwax Consensus Statement 2018; 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.