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Racemic menthol 1% w/w in talc

Cutaneous powder · 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 τελικού προϊόντος /100 g final product

IngredientSource quantityScaled quantity
Racemic menthol1 g—
Talcq.s. ad 100 g—

Prerequisite formulations

No separate prerequisite monograph is listed.

Documentation

Preparation description
White powder with a greasy feel and menthol odour. Contains 1 g racemic menthol per 100 g final product:1% w/w or 10 mg/g. Talc is the carrier. [1]
Action and use
Symptomatic relief of itching, pain or burning from mild skin irritation/insect bites as described by the source. For intact skin only, not infection treatment or mucosal application. Assess the need for a powder against a non-dusting alternative. [1]
Specifications
Final mass 100 g and strength 1% w/w, supported by current quantitative tables and the official 2019 edition [1,3]. Require uniform white powder without visible crystalline aggregates. No numerical assay or particle-size limits are given. [1], [3]
Light
Protect from light in the closed powder dispenser. The monograph defines no allowable direct-light exposure or photochemical test. [1]
Air and oxidation
Menthol is a volatile component; keep the container closed, minimise open mixing and avoid intentional airing. No inert gas is used. [1], [2]
Water and solubility
No water or aqueous solvent is added. Racemic menthol is practically insoluble in water [2], so adding water is not a homogenisation method. No finished-powder aw measurement is available. [1], [2]
Humidity
Protect from moisture; use dry equipment and check caking/flow. The source gives no numerical relative-humidity or water-content limit. [1]
Temperature
Racemic menthol melts at approximately 34 °C [2]. Avoid frictional overheating and hot storage. A cool controlled area no higher than 25 °C is selected here as a conservative handling condition, not a measured powder-stability limit. [1], [2]
pH and compatibility
The powder has no directly defined pH; no acid/base is added. Any aqueous-extract test requires a separate method and justified limit. [1]
Other interactions
Menthol can form eutectic mixtures with camphor, thymol and other substances and is incompatible with oxidisers [2]. Do not combine with thymol foot powder or another medicated powder without assessment. [2]
Ingredient-specific information
Use racemic menthol meeting RFE 0623; do not automatically substitute levomenthol or peppermint oil. Talc requires pharmacopoeial quality and impurity documentation; a generic cosmetic-product certificate does not qualify the batch [2,5]. [1], [2], [5]
Staff protection
Weigh/mix under local extraction with gloves and eye protection. Avoid respirable dust and compressed-air cleaning. NIOSH documents pulmonary hazards from occupational talc exposure [6]. [2], [6]
Risk assessment
Key risks are talc inhalation, wrong strength, application near nose/eyes and use in young children. The source contraindicates use under 2 years. IARC classifies talc as Group 2A; hazard classification does not quantify cancer risk for a particular short use [4]. Avoid genital/perineal application as a local measure against unnecessary exposure. [1], [2], [4]
Compounding conditions
For final massM g: menthol 0.01 M g and talc toM g. Independently verify decimal and percentage basis. The theoretical 100 g batch contains 1 g menthol and 99 g talc before losses. [1], [3]
BUD rationale
The source gives 3 months closed and protected from light/moisture. Use the earlier of 89 days/3 calendar months after local adoption of method/container and earlier material expiries. Conservative cool storage no higher than 25 °C is added because of racemic menthol [2]. No matched study or aw data were found; a generic 180-day period is not adopted. 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]
Prerequisites
No compounded base or solvent is required. Use only racemic menthol and pharmacopoeial talc, with supplier identity and certificates retained by lot. [1], [2]
Equipment
Suitable accurate balance, mortar/pestle, spatula and powder container. Any mixer must avoid appreciable heating and limit drug/powder losses. [1], [2]
Compounding method
Pulverise racemic menthol in the mortar. Progressively incorporate talc with trituration/mixing to distribute the 1 g drug uniformly. Check final mass and absence of visible aggregates, then pack promptly. No alcohol addition is specified. [1]
Observations
This sheet covers only the 1 g/100 g composition. Progressive geometric incorporation distributes the minor ingredient but does not replace uniformity assessment. The powder is nonsterile and not intended for wounds. [1], [3]
Container and packaging
Use a tightly closable powder dispenser protecting from light/moisture. Choose a controlled-flow outlet to avoid clouds. The source does not specify a particular container material. [1]
Quality control
Check lots and racemic identity,1% calculation, final mass and uniform appearance/flow. Do not inhale to assess odour. Quantitative uniformity and impurity testing require suitable methods and were not performed here. [1], [2], [5]
Storage
Keep closed, protected from light/moisture, in a cool area no higher than 25 °C as an additional local precaution. Avoid hot vehicles and humid bathrooms. Keep away from children. [1], [2]
Dispensing
Apply a small amount to clean, dry intact skin, avoiding face/nose, eyes, mucosa and inhalation. Do not use on open wounds, infection or exudative dermatitis. Contraindicated under 2 years; pregnancy/breastfeeding requires medical advice. Stop if irritation occurs. Contraindicated in hypersensitivity to any ingredient. [1]
Labelling
RACEMIC MENTHOL 1% w/w IN TALC — CUTANEOUS USE ONLY. Do not inhale/swallow. Not for children under 2 years, wounds or mucosa. Directions: ___. Batch/prepared/use by: ___. Keep closed, cool, protected from light/moisture. [1]
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: TALCO MENTOLADO (FN/2003/PO/028)2003 source code; current standalone PDF accessed 2026PDF pp.2–3, §§3–12 and patient leafletExact formula, process, finished appearance, source dating and route-specific precautions.2026-10-14
  2. AEMPS — FN/2003/PA/021: Mentol racémico2003 source code; current standalone PDFPDF p.2 §§3–10Racemic identity, approximately 34 °C melting point, solubility, eutectic incompatibilities and avoidance of nasal/mucosal contact.2026-10-13
  3. AEMPS/BOE — Formulario Nacional, second edition, October 2019 updateOctober 2019Printed p.515 (PDF 529); patient leaflet p.517 (PDF 531)Historical factual corroboration only: talco mentolado explicitly 1%, menthol 1 g/talc to 100 g. No protected layout or prose reproduced.2026-10-14
  4. IARC — Volume 136: evaluation of talc and acrylonitrile5 July 2024pp.1–3, talc evaluationTalc Group 2A hazard evaluation; separate from asbestos-containing talc. Hazard classification is not an individual dose-risk estimate.2026-10-13
  5. FDA — TalcCurrent page accessed 13 October 2026Asbestos: what it is and how to prevent its occurrence; testing summariesPotential asbestos contamination and importance of material selection/testing. Cosmetic surveillance does not validate a pharmaceutical batch.2026-10-13
  6. CDC/NIOSH — Talc, containing no asbestos and less than 1% quartzPocket Guide page accessed 13 October 2026Exposure routes, symptoms, target organs, preventionOccupational respirable-dust hazard; not NIOSH hazardous-drug classification.2026-10-13
  7. 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