Menthol 10% and methyl salicylate 15% analgesic ointment

Yellowish, greasy ointment with a characteristic odour.

References: [1]

Symptomatic topical relief of muscle and joint pain according to AEMPS.

References: [1]

Yellowish, greasy ointment with a characteristic odour. Quantities/raw-material quality follow §3. No specific numerical finished-product assay limit is provided.

References: [1]

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

References: [1]

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

References: [1]

Racemic menthol is practically insoluble in water and very soluble in ethanol under PA021.

References: [4]

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; protect 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.

References: [1]

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

References: [4]

Exact identities: Ρακεμική μενθόλη / Racemic menthol; Σαλικυλικό μεθύλιο / Methyl salicylate; Κίτρινος κηρός μελισσών / Yellow beeswax; Λανολίνη / Lanolin. 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.

References: [1]

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.

References: [2]

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]

Methyl salicylate 15%: repeated application over a large area can cause systemic toxicity. Consider allergy to salicylates or other ingredients.
Methyl salicylate: systemic toxicity with extensive application/overexposure.

References: [1] · [5]

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.

References: [1]

No separate compound base is required in the explicit formula.

References: [1]

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.

References: [2]

1. Melt yellow beeswax and lanolin in a 50–70°C water bath.
2. Cool while stirring until a consistency develops and transfer to a mortar.
3. Triturate menthol and dissolve it in methyl salicylate.
4. Incorporate the solution gradually into the base with continuous mixing.

References: [1] · [2]

Distinct from the BP methyl-salicylate-only ointment.

References: [1]

Tin tube as specified by the source; a different material requires compatibility assessment.

References: [1]

Menthol 10% and methyl salicylate 15% analgesic ointment
Quantity: _____ · Batch: _____ · Prepared: _____ · Use by: _____
External use only. Storage: Below 25°C; protect from light.
Patient/directions or laboratory use: _____ · Pharmacy/telephone: _____
Specimen for pharmacist adaptation; not a final approved label.

References: [1]

Under AEMPS: organoleptic properties and final mass. Batch production additionally requires spreadability PN/L/CP/003/00 and microbiological testing under RFE 5.1.4. The source does not specify a formula-specific active assay. Uniform appearance alone does not establish content uniformity.

References: [1] · [2]

Below 25°C; protect from light.

References: [1]

The source gives 2–3 applications/day to clean, dry skin without vigorous rubbing. Do not use under age 7 or on eyes, mucosa or wounds. Contraindicated with salicylate allergy. Review concomitant salicylates, pregnancy and breastfeeding.

References: [1]