Menthol 1% and thymol 1% rubefacient in rosemary spirit

Clear colourless liquid with a characteristic odour.

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AEMPS describes external rubbing for symptomatic relief of muscle/joint pain and mild itching.

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Clear colourless liquid with a characteristic odour. Quantities/raw-material quality follow §3. No specific numerical finished-product assay limit is provided.

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The finished preparation is stored protected from light under the monograph.

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Ethanol generates vapour; limit time in open vessels. Evaporation can change composition (editorial process assessment).

References: [6]

Ethanol is miscible with water. This does not establish that all dissolved actives remain soluble after dilution.
Racemic menthol is practically insoluble in water and very soluble in ethanol under PA021.

References: [4] · [6]

No specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.

References: [1]

Finished-product storage: Below 25°C, tightly closed and protected from light. Processing follows the method-specific temperatures.

References: [1]

No specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.

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Menthol forms eutectic mixtures with camphor/thymol; incompatible with strong oxidants.
Thymol: incompatible with oxidants/alkalis; proteins reduce antiseptic action.
Ethanol is incompatible with strong oxidants.

References: [4] · [5] · [6]

Exact identities: Ρακεμική μενθόλη / Racemic menthol; Θυμόλη / Thymol; Οινόπνευμα δενδρολίβανου PO035 / Rosemary spirit PO035. Use pharmacopoeial raw materials of the referenced edition, with CoA verification. Do not arbitrarily change salt, hydration state or strength. Record the actual q.s. amount in the batch.

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Laboratory environment under the referenced AEMPS procedure: 25±5°C and relative humidity ≤60%, unless the specific formulation requires otherwise. Room temperature differs from processing temperature.

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Clean protective clothing and head covering under AEMPS PN/L/PG/002/00. Use suitable gloves where contact is possible and respiratory/eye protection where powder handling requires it. Exact glove material, ventilation and respiratory protection must follow the SDS and local exposure assessment.
Menthol: eye protection and prevention of contact/dust inhalation.

References: [3] · [4]

Possible irritant/allergic dermatitis and inhalation irritation. Ingestion can cause severe toxicity. The vehicle has a high alcohol content.
Ethanol: flammable vapour; control ignition sources and provide suitable ventilation. Final classification depends on concentration/mixture.

References: [1] · [6]

The specific monograph states 3 months under its specified conditions. This is a source period, not independently verified stability of the local batch. Match composition, preservative, container and storage, check applicable requirements and obtain responsible approval. The actual date remains blank.

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CGR-ES-076 — Αλκοολικό διάλυμα αιθέριου ελαίου δενδρολίβανου 5% / Rosemary essential oil alcoholic solution 5% v/v
Referenced bases are included in the package; also check their dependencies.

• CGR-ES-076 · Rosemary essential oil alcoholic solution 5% v/v

References: [1] · [7]

Balance with suitable resolution, mortar/spatula, suitable mixing vessels and final container. Add volumetric equipment for mL, a controlled water bath where melting is specified and a suitable filter where required. Analytical equipment follows the QC methods.

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1. Prepare and check rosemary spirit 5% PO035.
2. Dissolve menthol and thymol in part of the vehicle.
3. Filter and make up to 100 mL with the same vehicle under PN/L/FF/007/00.

References: [1] · [2]

The master formula is 100 mL. The leaflet heading “100 g” conflicts with its own ad 100 mL and is not used to change the formula basis.

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Amber glass bottle.

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Menthol 1% and thymol 1% rubefacient in rosemary spirit
Quantity: _____ · Batch: _____ · Prepared: _____ · Use by: _____
External use only. Storage: Below 25°C, tightly closed and protected from light.
Patient/directions or laboratory use: _____ · Pharmacy/telephone: _____
Flammable. Keep away from flames. Do not swallow.
Specimen for pharmacist adaptation; not a final approved label.

References: [1] · [6]

Under AEMPS: organoleptic properties and final mass and/or volume. For batches: colour RFE 2.2.2, clarity/opalescence RFE 2.2.1, relative density RFE 2.2.5, pH under PN/L/CP/001/00 and microbiological testing under RFE 5.1.4. This formula provides no numerical pH/density limits or specific active assay.

References: [1] · [2]

Below 25°C, tightly closed and protected from light.

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DO NOT SWALLOW. EXTERNAL USE ONLY. The source gives 2–3 applications/day with gentle rubbing. Do not use under age 2, on open wounds or mucosa, or near the nose. Pregnancy/breastfeeding require medical assessment.

References: [1]