Methyl salicylate 1%, menthol 3% and camphor 2.5% w/w analgesic cream · CGR-ES-104 (CGR-ES-104)

REFERENCE FORMULA

Reference formula

Reference basis: 100 g τελικής κρέμας / final cream

Ingredient	Source quantity	Scaled quantity
Methyl salicylate	1 g	—
Racemic menthol	3 g	—
Racemic camphor	2.5 g	—
Ethanol 96%	1 mL	—
Nonionic O/W emulsion 2, FN/2003/EX/011 / CGR-ES-020	q.s. ad 100 g	—

Prerequisite formulations

CGR-ES-020 · Nonionic O/W Emulsion 2 EX011

Documentation

Preparation description

Whitish aromatic O/W cream containing 1 g methyl salicylate,3 g racemic menthol and 2.5 g racemic camphor per 100 g [1]. Vehicle 2 is a specific nonionic base with an aqueous phase, not plain petrolatum [2]. ^{[1], [2]}

Action and use

Source: symptomatic topical relief of muscle/joint discomfort. Determine clinical suitability and duration individually; equivalent efficacy to other-strength commercial products is not assumed. Severe pain, inflammation or injury should not be masked by indiscriminate repeated application. ^{[1], [3]}

Specifications

Source: whitish cream with characteristic aromatic odour. Check uniformity, absence of crystals/separation and final mass. No numerical pH, viscosity, aw or final-product AET is supplied. Odour does not demonstrate retention of volatile APIs. ^{[1], [2], [7]}

Light

Use opaque packaging and protect from light/heat as specified. Retained characteristic odour/colour does not extend the use-by date. ^[1]

Air and oxidation

Close vessels promptly to limit camphor/ethanol loss [4,5]. Do not deliberately aerate mixing to remove solvent. Volatile loss changes composition and is not corrected by arbitrary addition. ^{[1], [4], [5]}

Water and solubility

Water enters throughEX 011. Do not add more to reduce viscosity. Incorporating the actives dilutes/modifies the base’s preservation system; this is not equivalent to AET of the finished cream [2]. ^{[1], [2]}

Humidity

Keep tightly closed to limit aqueous-phase drying and contamination. The base specifies moisture protection [2] without numericalaw. Use clean dry incorporation tools. ^{[1], [2], [7]}

Temperature

Below 30 °C. The 60–65 °C step concerns separate base preparation [2], not heating the final volatile-active mixture. Incorporate into suitably cooled/checked base away from ignition sources [4,5]. ^{[1], [2], [4], [5]}

pH and compatibility

No final pH is specified. If monitored, use an appropriate O/W-cream method and record without an invented limit. Do not add acid/base, which may alter emulsion, actives and preservation. ^{[1], [2], [7]}

Other interactions

Avoid co-application of other local irritants. Do not use heating pads/external heat or tight occlusion [3,6]. Store concentrates separately from strong oxidants under their SDSs; compatibility with every plastic is not assumed [1]. ^{[1], [3], [4], [5], [6]}

Ingredient-specific information

Use methyl salicylateRFE 0230, racemic mentholRFE 0623 and racemic camphorRFE 0655. Measure 96% ethanol as 1 mL, not 1 g. EX 011 contains 18% cetearyl alcohol,12% liquid paraffin,2.5% polysorbate 80, 5% propylene glycol and preserved waterq.s. [2]; final concentrations depend on actual base mass. ^{[1], [2]}

Staff protection

Use gloves compatible with actives/solvent, eye protection and camphor/menthol dust control. Provide suitable ventilation and exclude flames/sparks during dissolution. Camphor ingestion/neurotoxicity hazards also require safe laboratory handling [4,5]. ^{[4], [5], [7]}

Risk assessment

Clinical risks include irritation/serious burns with menthol [3], salicylate/NSAID hypersensitivity and accidental-ingestion toxicity [1,4]. Avoid damaged/burned skin, eyes and mucosa. Paediatric use, pregnancy and breastfeeding require specific review, not automatic clearance from a historical age caution. Process risks include incomplete dissolution, crystallisation, emulsion breakdown and unsuitable packaging. ^{[1], [3], [4], [6], [7]}

Compounding conditions

For M g:0.01 M g methyl salicylate,0.03 M g menthol,0.025 M g camphor,0.01 M mL 96% ethanol and base to M g. Include the mass of 1 mL ethanol in final weighing; do not calculate 93.5 g base while ignoring solvent mass. ^{[1], [2], [7]}

BUD rationale

Source:3 months below 30 °C in suitable opaque packaging [1]. No full primary study of the exact 1%/3%/2.5% composition inEX 011 orAET/aw evidence was identified. The reference ceiling is 89 days and≤3 calendar months only with documented local adoption of process, container and controls. The base’s 6-month period does not transfer [2]. Incomplete dissolution/crystallisation or altered ethanol prevents applying this period. Earlier material expiry prevails. 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], [2], [7]}

Prerequisites

CGR-ES-020 / FN/2003/EX/011 nonionicO/W base 2. Verify preserved water and full base composition/batch. Do not substituteO/W base 1, a general moisturiser or anhydrous ointment. Prepare the base separately before active incorporation. ^{[1], [2]}

Equipment

Suitable balance,1 mL volumetric measure, small covered dissolution vessels, mortar/cream mixer and compatible opaque packaging. Equipment must allow checking solutions and small crystals without testing on staff skin. ^{[1], [7]}

Compounding method

1. Dissolve menthol in methyl salicylate as specified. 2. Separately dissolve camphor in the stated ethanol. 3. Combine and progressively incorporate intoO/W base 2. 4. Add base to final 100 g, inspect and package. The method says “minimum ethanol” while the table fixes 1 mL: if the prescribed amount cannot achieve required dissolution, stop for approved assessment rather than adding extra solvent arbitrarily. ^{[1], [2], [7]}

Observations

Nominal per g:10 mg methyl salicylate,30 mg menthol and 25 mg camphor. Verify complete pre-incorporation dissolution and absence of recrystallisation in the actual process. Odour does not replace proof of uniformity. ^{[1], [7]}

Container and packaging

Use opaque tight packaging with demonstrated compatibility with menthol/camphor/methyl salicylate. The source warns that some plastics are unsuitable. Do not select a plastic container solely by appearance. ^{[1], [7]}

Quality control

Check exact weights/solvent volume, complete intermediate dissolution, final mass, uniformity and absence of crystals/separation. Inspect a thin smear and container suitability. Perform volatile-component assay/microbiology where required by the approved plan; no unperformed results are claimed. ^{[1], [2], [7]}

Storage

Below 30 °C in an opaque tightly closed container, protected from heat. Do not use a heating pad during application. Quarantine separation, crystallisation or significant texture change. Keep away from children. ^{[1], [3], [6]}

Dispensing

External application only to the agreed intact-skin area. Avoid eyes/mucosa, heat and tight bandaging. Wash hands after use. Stop and obtain prompt assessment for severe pain, swelling or blistering [3]. Store securely because ingestion is hazardous. ^{[1], [3], [4], [6]}

Labelling

Methyl salicylate 1% / menthol 3% / camphor 2.5% — CREAM. External use only. Directions: __. Avoid wounds, eyes and mucosa. No heating pads/tight occlusion. Stop for pain, swelling or blistering. Below 30 °C, tightly closed, away from children. Batch: __. Prepared: __. Use by: __. compounding.gr. ^{[1], [3], [6], [7]}

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

AEMPS — Formulario Nacional: CREMA ANALGÉSICA DE SALICILATO DE METILO, MENTOL Y ALCANFORFN/2006/PO/037; current standalone PDFPDF p.2 formula/method/container/BUD; subsequent patient and safety sectionsMaster formula; independently adapted, not an official translation2026-10-14
AEMPS — FN/2003/EX/011 Emulsión O/A no iónica 2Current standalone sourcePDFp.2 entire base formulaExact cetearyl alcohol/liquid paraffin/polysorbate 80/propylene glycol/preserved-water base; not finished analgesic preservation validation2026-10-13
Health Canada — Safety review of menthol/methyl salicylate/capsaicin topical pain relievers and serious skin burns13 February 2017; page 4 May 2017Key messages and conclusionsClass safety signal for menthol-containing topical products; no frequency or efficacy claim for this exact formula2026-10-13
ILO/WHO — ICSC1021 CamphorJuly 2003; current official card retrieved 2026Properties, handling and health effects; note on racemic formCamphor volatility/limited water solubility and ingestion/exposure hazards, not formulation stability2026-10-13
ILO/WHO — ICSC0044 Ethanol (anhydrous)May 2018Fire/explosion; handling; chemical incompatibilitiesRaw ethanol hazards; numerical anhydrous flash point is not assigned to finished mixtures2026-10-13
FDA — Clinical Review NDA22029/S-012 Salonpas20 February 2013Section 8 postmarketing experience; heat/burn discussionHeat-associated topical salicylate/menthol harm; patch composition/efficacy and age authorisation do not transfer2026-10-13
Ministerio de Sanidad — Guía de buenas prácticas de preparación de medicamentos en servicios de farmacia hospitalariaJune 2014; official AEMPS copyAnnexes 3–4, PDF pp.51–58Nonsterile preparation risk assessment, equipment, packaging and quality controls; not Greek legislation2026-10-13
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