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Gomenol 2% w/w cutaneous oil solution

Cutaneous oil solution · Spain · AEMPS

2026-10-14Reference document · Local adoption required

Collection and scientific editing: Stasinos Chr. SikaliasContent edition: 10.0Record editorial review date: 2026-10-14

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REFERENCE FORMULA

Reference formula

Reference basis: 100 g / 100 g

IngredientSource quantityScaled quantity
Gomenol, pharmaceutical raw material2 g—
Virgin olive oil98 g—

Prerequisite formulations

No separate prerequisite monograph is listed.

Documentation

Preparation description
Homogeneous oil solution with the colour of virgin olive oil. Strength is 2 g gomenol per 100 g mixture, not 2 g per 100 mL. [1]
Action and use
The Spanish source describes cutaneous use for wounds, dermatitis, burns and ulcers, with twice-daily application. This records its source indication, not comparative efficacy evidence or permission for nasal or oral administration. Extensive lesions require an individual clinical decision. [1], [2]
Specifications
Verify gomenol identity/CoA and virgin olive oil meeting the cited RFE 0518 standard. The source gives olive-oil colour as a finished characteristic; it supplies no terpene assay, pH or potency limits. Local checks should include homogeneity and absence of separation. [1], [2], [3]
Light
Use an amber bottle and protect from light as specified by the master. This is a storage requirement for the oil, not a quantitative photostability result. [1]
Air and oxidation
The source specifies full, tightly closed bottles. Select a size that limits headspace and close promptly after mixing, without overfilling that impairs safe closure. [1]
Water and solubility
No water is added. Use dry equipment and do not dilute with water, which creates a different, potentially biphasic preparation. No measured aw supports automatic use of a 180-day category. [1], [3], [4]
Humidity
The general solutions procedure specifies room relative humidity at or below 60%. No formulation-specific humidity study is provided; prevent water entry during weighing and filling. [1], [3]
Temperature
Prepare by simple mixing; no heating step is specified. Store below 25 °C. Refrigeration, freezing and temperature cycling have not been established as equivalent conditions by this source. [1]
pH and compatibility
No pH is specified for this nonaqueous oil system. Neither a numerical pH nor an aqueous-extraction pH procedure is a specification of this monograph. [1]
Other interactions
Do not substitute eucalyptus or tea-tree oil for gomenol. The French nasal medicine contains niaouli oil and an additional excipient; it is neither an equivalent raw material nor stability/compatibility evidence for this formula. [1], [2]
Ingredient-specific information
The Spanish master does not state gomenol botanical identity. The official French SmPC identifies gomenol oil as Melaleuca quinquenervia (Cav.) S.T.Blake essential oil. Match the purchased pharmaceutical raw material to its documented identity and composition rather than relying on a trade name. Olive oil is the lipid vehicle. [1], [2]
Staff protection
When weighing the concentrated essential oil, use gloves compatible with that material, eye protection and controlled ventilation. Avoid direct contact, aerosol generation and sniffing the container. Select glove material and any local extraction from the supplier SDS for the actual raw material. [1], [2], [3]
Risk assessment
Principal risks are irritation and allergic reactions, particularly in children. The comparator SmPC identifies terpene neurotoxicity with excessive exposure; its nasal doses and age limits cannot simply be transferred to this cutaneous formula. Do not apply to the breast during lactation. Assess age, treated surface, skin integrity, seizure history and accidental ingestion risk. [1], [2]
Compounding conditions
Verify identity and condition of both materials. Weigh 2.00 g gomenol and 98.00 g oil for 100 g; apply the same scaling factor to both masses. Use clean dry equipment in the general procedure environment of 25±5 °C, with finished-product storage consistently below 25 °C. [1], [3]
BUD rationale
The master allows one month in full, tightly closed amber bottles, protected from light below 25 °C. No complete stability study for the exact formula/raw material was identified. Under a documented local source-specific adoption with material and packaging controls, use the earliest of 28 days, one calendar month and remaining ingredient limits. This is a source ceiling, not validated experimental evidence or an aw-based USP category. Editorial convention: calendar-month source periods are retained as calendar periods; the calendar-period conversion ceiling is 28 days for one month or 89 days for three months; a separately selected shorter ceiling still governs. It is a conservative conversion, not a source quotation. [1], [4]
Prerequisites
No intermediate base is required. Dependencies are an approved gomenol raw-material specification, source-compliant virgin olive oil, the solutions procedure and documented labelling/release procedures. [1], [3]
Equipment
Balance suitable for a 2 g charge, dry glass beaker, spatula or low-shear stirrer, and amber bottle with compatible closure. No heating or sterilisation equipment is required by the method. [1], [3]
Compounding method
1. Weigh the two ingredients separately. 2. Add gomenol to virgin olive oil. 3. Mix until homogeneous without introducing water or unnecessary aeration. 4. Check appearance and mass, fill and close promptly. The master specifies no dilution, heating or filtration. [1], [3]
Observations
The name gomenolated oil does not by itself determine route. This record covers only the Spanish 2/98 w/w cutaneous composition. The concentration of an individual terpene cannot be calculated without the raw-material composition. [1], [2]
Container and packaging
Amber bottle, tightly closed and appropriately full as specified, with a closure compatible with essential and fixed oils. The presentation and label must make cutaneous use clear and avoid confusion with nasal drops. [1], [2], [3]
Quality control
Verify weights, final mass, uniform appearance and olive-oil colour. The general procedure includes additional batch checks where applicable; this master gives no terpene assay range, microbiological release result or pH limits. Enter actual test results during execution. [1], [3]
Storage
Store below 25 °C, protected from light, tightly closed. Do not use after the authorised use-by date or if separation or altered odour/appearance occurs. These observations trigger investigation; their absence does not prove stability. [1], [3]
Dispensing
Dispense with a cutaneous indication and individual directions. Check age, allergies and lesion extent; avoid breasts during lactation and contact with eyes/mucosa. Explain that it is not a nasal medicine and must not be swallowed. [1], [2]
Labelling
Gomenol 2% w/w in virgin olive oil — cutaneous use only. Apply as prescribed. Do not swallow. Not for nasal use. Store below 25 °C, protected from light, tightly closed. Keep away from children. Batch / quantity / preparation date / authorised use-by date: complete during execution. [1], [2]
v9_controls
The numeric value is a literature reference ceiling subject to its specific conditions. No actual batch BUD has been assigned and no aw measurements have been produced. The exact formula, prerequisites, container, storage and quality evidence require approval for the actual application. The BUD clock starts when compounding begins. Use the shortest applicable supported limit and assess in-use dating separately. USP categories are a technical framework and are not presented as Greek legislation.

Sources and references

  1. AEMPS, Formulario Nacional — ACEITE GOMENOLADO (FN/2003/PO/002)FN/2003 source identifier; current standalone official PDF accessed 2026-10-13PDF pp. 2–3; composition, specific method, storage, validity and patient leafletMaster composition, preparation and source-specific conditions. Independently written factual adaptation; not an official translation or endorsement. No laboratory testing performed for this document.2026-10-14
  2. French public medicines database — HUILE GOMENOLEE 2 POUR CENT, solution pour instillation nasale, SmPCSmPC 17 February 2026; page accessed 13 October 2026Sections 2, 4.3–4.6, 6.1Identification of pharmaceutical niaouli essential oil (Melaleuca quinquenervia) and terpene-related hazards. This nasal medicine has an additional excipient and is not the Spanish cutaneous formula; its doses, age limit and shelf life are not transferred.2026-10-13
  3. AEMPS — Elaboración de soluciones (PN/L/FF/007/00)Official FN procedure, version 00, accessed 2026-10-13Sections 5–6: environment, preparation, packaging, finished-product checksOfficial general dosage-form procedure; exact formula method takes precedence; batch-level tests are distinct from tests actually performed.2026-10-13
  4. USP — Compounding Standards and Beyond-Use DatesNovember 2022 update, official USP fact sheet hosted by Mississippi Board of PharmacyNonsterile preparation BUD overview and category tableGeneral BUD framework; an AEMPS source period is not automatically a USP–NF monograph exception, and no measured water activity is implied.2026-10-13
  5. USP — General Chapter <795> Frequently Asked QuestionsNovember 1, 2023 FAQ; rechecked 14 October 2026Questions 52, 54–56, 61, 64–66General category/extension rules only; not exact-product stability evidence.2026-10-14