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Menthol spirit 5% w/v PO012

CGR-ES-064 · FN/2003/PO/012 ALCOHOL MENTOLADO AL 5%

For local reviewCGR-ES-064Spain · AEMPS

WORKSHEET FOR LOCAL APPROVAL — source authority does not replace batch approval.

Inhalation directions differ between main text and leaflet. This adaptation covers cutaneous use only.

Inhalation directions differ between main text and leaflet. This adaptation covers cutaneous use only.

Monograph PDF · GR/ENBlank batch worksheet
Dosage formCutaneous solution
Reference batch100 mL
Monograph version4.0
Source packagev4

Source formula

IngredientSource quantity
Racemic menthol5 g
Ethanol 96%q.s. ad 100 mL

Quantities refer to the source batch. This website does not automatically scale formulas, assign doses or calculate BUD.

Description

Documented in source

Transparent colourless liquid with menthol odour.

References: [1]

Use and action

Documented in source

Cutaneous relief of mild muscle/joint pain, itching and irritation according to the source.

References: [1]

Specifications

Documented in source

Transparent colourless liquid with menthol odour.

References: [1]

Light

Partial evidence

For the finished product the source specifies:
Amber glass bottle, protect from light/moisture, <25°C.

References: [1]

Air

Not established

No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

References: [1]

Water and solubility

Not established

No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

References: [1]

Humidity

Partial evidence

For the finished product the source specifies:
Amber glass bottle, protect from light/moisture, <25°C.

References: [1]

Temperature

Partial evidence

For the finished product the source specifies:
Amber glass bottle, protect from light/moisture, <25°C.

References: [1]

pH and related incompatibilities

Not established

No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

References: [1]

Other incompatibilities

Partial evidence

Menthol forms eutectic mixtures with camphor/thymol; incompatible with strong oxidants.
Ethanol is incompatible with strong oxidants.

References: [2] · [3]

Ingredient-specific information

Partial evidence

Racemic menthol: Menthol forms eutectic mixtures with camphor/thymol; incompatible with strong oxidants.
Ethanol 96%: Ethanol: flammable vapour; control ignition sources and provide suitable ventilation. Final classification depends on concentration/mixture.
These are selected facts for identified ingredients; relevant sensitivities and incompatibilities are detailed in the corresponding fields. This is not a complete SDS for every material.

References: [2] · [3]

Personal protective equipment

Partial evidence

Menthol: eye protection and prevention of contact/dust inhalation.
Supplementary AEMPS framework: clean long-sleeved laboratory clothing, hair covering and dedicated footwear/overshoes. Powder handling requires suitable eye/respiratory protection; change gloves with activity or damage. Select the exact type/material using SDS and risk assessment.

References: [2] · [4]

Risks and precautions

Partial evidence

Ethanol: flammable vapour; control ignition sources and provide suitable ventilation. Final classification depends on concentration/mixture.

References: [3]

Compounding conditions

Documented in source

The corresponding AEMPS SOP specifies room temperature 25 ± 5°C and relative humidity ≤60%, unless the particular formula requires otherwise. This is the work environment, not processing or storage temperature.
Follow the addition sequence, temperatures and times stated under Preparation Procedure. The specific monograph is not a complete qualification of the local facility/equipment.

References: [1] · [5]

BUD rationale

Documented in source

3 months under the source conditions.
The source period applies to its exact composition, method and packaging. It is not this batch’s expiry date and cannot be transferred to another vehicle/strength. Calculate the actual date in the blank batch record.

References: [1]

Bases and dependencies

Partial evidence

No separate base is identified in the dependency register. Check any commercial vehicles/compound excipients listed in the formula.

References: [1]

Equipment

Editorial checklist

Indicative checklist derived from the method: Balance of suitable resolution, Containers and mixing tools compatible with the materials, Suitable filtration medium. Selection/qualification is defined locally.

References: [1]

Preparation procedure

Documented in source

Dissolve menthol in 96% ethanol and filter.

References: [1] · [5]

Observations

Documented in source

The source also describes vapour inhalation with differing dilutions in the main text and leaflet. This adaptation is restricted to cutaneous use; no inhalation instruction is adopted without clarification.

References: [1]

Packaging

Documented in source

Amber glass bottle, protect from light/moisture, <25°C.

References: [1]

Quality control

Partial evidence

Transparent colourless liquid with menthol odour.
Additional tests from the referenced SOP:
Appearance and mass/volume. For batches: colour, clarity/opalescence, relative density, pH and microbiological testing RFE 5.1.4.
pH under PN/CP/001: normally test the untreated sample unless otherwise specified. Accurate measurement follows potentiometric RFE 2.2.3; strips are limited to checks not requiring high accuracy.

References: [1] · [5] · [6]

Storage

Documented in source

Amber glass bottle, protect from light/moisture, <25°C.

References: [1]

Dispensing and directions

Documented in source

DO NOT SWALLOW. External use only. Not under 2 years or on open wounds/mucosa.

References: [1]

Labelling

editorial_specimen

Menthol spirit 5% w/v PO012
Strength/variant: __________ Quantity: __________
Batch: __________ Prepared: __________ Use by: __________
Εξωτερική χρήση / External use
Dose/directions: __________
Storage: Amber glass bottle, protect from light/moisture, <25°C.
DO NOT SWALLOW. External use only. Not under 2 years or on open wounds/mucosa.

References: [1]

Sources and traceability

  1. FN/2003/PO/012 ALCOHOL MENTOLADO AL 5%

    FN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022 · PDF pp. 2–3 · A1

    Review date reported in supplied metadata: 2026-09-10

  2. FN/2003/PA/021 MENTOL RACÉMICO

    Διαθέσιμο κείμενο / Retrieved text · PDF pp. 1–2 · A1

    Review date reported in supplied metadata: 2026-09-10

  3. niosh_ethanol

    Διαθέσιμο κείμενο / Retrieved text · Official reference · A1

    Review date reported in supplied metadata: 2026-09-10

  4. PN/L/PG/002/00 INDUMENTARIA

    Διαθέσιμο κείμενο / Retrieved text · PDF pp. 1–5 · A1

    Review date reported in supplied metadata: 2026-09-10

  5. PN/L/FF/007/00 ELABORACIÓN DE SOLUCIONES

    Διαθέσιμο κείμενο / Retrieved text · PDF pp. 1–6 · A1

    Review date reported in supplied metadata: 2026-09-10

  6. PN/L/CP/001/00 DETERMINACIÓN DE PH

    Διαθέσιμο κείμενο / Retrieved text · PDF pp. 1–5 · A1

    Review date reported in supplied metadata: 2026-09-10

Provenance and reuse

This record comes from the supplied v4 collection. Primary-source rights and licences remain separate. No new comprehensive licence review has been performed for the earlier 239 records.

SHA-256 of the supplied PDF: e27906bec70cded55825aa8164ef1b565867dc954547338e35d93a197f220874

Monograph PDF · GR/ENBlank batch worksheet