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Topical antibacterial / Antifungal (ear) Pregnancy: UK SPC §4.6, verbatim and complete: 'There are no known restrictions to the use of the product in pregnancy and lactation.' The US otic label in this bundle contains no pregnancy, lactation or fertility section.

Acetic Acid 2% (Ear Drops)

Brand names: EarCalm, Otomize (with neomycin/dexamethasone)

Acetic acid ear drops are a topical preparation used to treat infections of the outer ear canal (otitis externa). The acidic preparation restores the normal acidity of the ear canal and has antibacterial and antifungal activity.

Adult dose

Dose: One metered dose (60 milligrams) administered directly into each affected ear
Route: Topical — 'For external aural use to the external auditory canal only.' The sourced UK product is a metered-dose SPRAY (EarCalm Spray), not a drop bottle; the page is titled 'Ear Drops', so present the delivery device accordingly.
Frequency: At least three times daily (morning, evening and after swimming, showering or bathing). 'Maximum dosage frequency one spray every 2 - 3 hours.' 'Treatment should be continued until two days after symptoms have disappeared but no longer than 7 days.'
SCOPE: this is the page's primary indication and route — UK SPC §4.2, verbatim: 'Adults, children, aged 12 years and above, and the elderly. For treatment of superficial infections of the outer ear: one metered dose (60 milligrams) to be administered directly into each affected ear at least three times daily (morning, evening and after swimming, showering or bathing). Maximum dosage frequency one spray every 2 - 3 hours. Treatment should be continued until two days after symptoms have disappeared but no longer than 7 days.' || WHY maxDose IS EMPTY: the only ceiling in the source caps FREQUENCY ('one spray every 2 - 3 hours'), not the size of a dose, so it belongs in the frequency field rather than in a maximum-dose field. It is quoted verbatim there. || PRIMING AND SHELF LIFE (§4.2, verbatim): 'Before using the product for the first time, prime the pump by depressing actuator 6 - 10 times until a fine spray is obtained. Use within 1 month of first actuation. If more than one week has elapsed since the last use, dispose of the contents of the pump chamber by 1 or 2 depressions of the actuator.' || The US otic solution label does give a drops regimen — verbatim: 'Carefully remove all cerumen and debris to allow acetic acid otic solution to contact infected surfaces directly. To promote continuous contact, insert a wick of cotton saturated with acetic acid otic solution into the ear canal; the wick may also be saturated after insertion. Instruct the patient to keep the wick in for at least 24 hours and to keep it moist by adding 3 drops to 5 drops of acetic acid otic solution every 4 hours to 6 hours. The wick may be removed after 24 hours but the patient should continue to instill 5 drops of acetic acid otic solution 3 times or 4 times daily thereafter, for as long as indicated.' — but that dose is a strength-free DROP COUNT: the label text never states a percentage and the product name is only 'Acetic Acid', so the strength is not pinned and the count cannot be published as a dose.

Paediatric dose

Route: Topical — external auditory canal only.
Frequency: Children aged 12 years and above: as for adults — at least three times daily (morning, evening and after swimming, showering or bathing), maximum one spray every 2 - 3 hours, for no longer than 7 days.
dosePerKg is null and concentration is null because this is a fixed topical dose, not a weight-based one. || UK SPC §4.2 gives a single posology covering 'Adults, children, aged 12 years and above, and the elderly' — one metered dose (60 milligrams) into each affected ear. There is therefore NO separate paediatric dose for 12-17 year olds; they take the adult dose. || UNDER 12 YEARS — no dose is stated in the UK source. §4.3, verbatim: 'Not recommended for children under 12 years of age without medical advice.' || The US otic solution label says 'In pediatric patients, 3 drops to 4 drops may be sufficient due to the smaller capacity of the ear canal' and 'Safety and effectiveness in pediatric patients below the age of 3 years have not been established' — but that product's acetic acid strength is not stated anywhere in the bundle, so no drop count is published here. || For any child, verify against a children's formulary and confirm the tympanic membrane is intact before instilling anything into the ear canal.

Dose adjustments

Renal

Not stated. No renal-impairment statement appears in any fetched section of either the UK SPC or the US otic label for this topical product.

Hepatic

Not stated. No hepatic-impairment statement appears in any fetched section of either the UK SPC or the US otic label for this topical product.

Dose independently re-sourced from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • UK SPC §4.3, verbatim: 'The product should not be used in patients with a known sensitivity to any of the ingredients.'
  • UK SPC §4.3, verbatim: 'Not recommended for children under 12 years of age without medical advice.'
  • US otic label CONTRAINDICATIONS, verbatim: 'Hypersensitivity to acetic acid otic solution or any of the ingredients. Perforated tympanic membrane is considered a contraindication to the use of any medication in the external ear canal.'
  • Not a UK contraindication but a UK §4.4 restriction: 'Patients who are known to have a perforated ear drum should only use the product under medical supervision.' (The US label treats a perforated tympanic membrane as an outright contraindication — the two labels differ; take the stricter position.)
  • Not a contraindication but a UK §4.4 instruction: 'Avoid spraying near the eyes.'

Side effects

  • UK SPC §4.8, verbatim and complete: 'Some patients may experience a transient stinging or burning sensation after dosing for the first few days of treatment.'
  • US otic label ADVERSE REACTIONS, verbatim and complete: 'Stinging or burning may be noted occasionally; local irritation has occurred very rarely.'

Monitoring

  • UK SPC §4.4, verbatim: 'If pain occurs during use, or if symptoms worsen or do not improve within 48 hours, or if your hearing becomes impaired, stop treatment and consult your doctor.'
  • UK SPC §4.4, verbatim: 'Do not use for more than 7 days.' §4.2 adds: 'Treatment should be continued until two days after symptoms have disappeared but no longer than 7 days.'
  • Tympanic membrane integrity before and during use — UK §4.4 requires medical supervision if the ear drum is known to be perforated; the US label makes a perforated tympanic membrane a contraindication to any external-ear-canal medication.
  • UK SPC §4.5: 'Interaction with other medicinal products and other forms of interaction — None known.'

Clinical monograph

How it works

Acetic acid lowers the pH of the ear canal, creating an acidic environment that inhibits the growth of bacteria and fungi commonly responsible for otitis externa.

Prescribing in practice

  • It should not be used if the eardrum is known or suspected to be perforated, and treatment should be reviewed if symptoms do not improve, to reconsider the diagnosis.
  • It may cause transient stinging or burning in the ear on application.
  • It is intended for short-term topical use in the external ear canal only.

Monitoring

Review clinical response over the course of treatment and reassess if symptoms persist, worsen, or fail to settle within the expected period.

Counselling the patient

  • Use the drops in the affected ear as directed and avoid getting water in the ear.
  • A brief stinging sensation after putting the drops in is common and usually settles.
  • See your clinician if the ear does not improve, becomes more painful, or starts to discharge.

Evidence & guidelines

Topical acidifying preparations are a long-established treatment for otitis externa, supported by clinical practice and guidance for ear canal infections.

Reference: NICE NG91 Otitis Externa; SIGN 66; 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.