Final editorial decision
Documented FTM reference monograph — exact composition and source duration.
The wax is defined exactly as 80% cetostearyl alcohol and 20% cetomacrogol 1000. Use an identified pharmaceutical grade with documented composition. An anionic emulsifying wax or another blend is not an automatic substitute. The source and formula were reverified; release always concerns the actual batch.
FTM 2010 states 2 calendar months at 15–25 °C in the specified 300 mL amber-glass bottle for a 200 g preparation. After opening: up to 2 calendar months, always within the overall use-by date. This is a specific official historical formulary instruction, not a new experimental study. The responsible pharmacist adopts the duration only for the exact formula, process, container and storage, applying any shorter limit. No aw measurement has been made and the website does not automatically assign a batch BUD.
Amber-glass bottle as specified by the source; 15–25 °C. Shake before use. A different temperature or container requires separate assessment.
Required evidence
- Controlled official FTM D-I-4-b-2 with exact composition and original approximately 70 °C process.
- Specification and supplier evidence/CoA for 80% cetostearyl alcohol +20% cetomacrogol 1000 wax; a controlled intermediate record if locally compounded.
- Record of source applicability, actual compounding, storage and release.
Closure criteria
- The source record and exact wax definition are documented; this closes the documentary identity issue without claiming laboratory testing.
- The batch uses the exact formula and original 300 mL amber-glass bottle/200 g at 15–25 °C; applicable quality checks and pharmacist approval pass.
- Reference duration up to 2 calendar months; after opening up to 2 months only within the overall date. Batch dating applies the shortest supported limit.
Scope
Final editorial decision dated 14 October 2026. This is not a certificate of laboratory results or actual batch release.
Sources and references
- FAMHP/AFMPS, Formulaire Thérapeutique Magistral 2010, D-I-4-b-2PDF pp.267–268 (zero-index pages 266–267), D-I-4-b-2.1–2.2; general analytical norms PDF p.15
- USP General Chapter <795> FAQs, updated 1 November 2023Q52, Q54–56, Q58–65, PDF pp.11–15
REFERENCE FORMULA
Reference formula
Reference basis: 200 g
| Ingredient | Source quantity | Scaled quantity |
|---|---|---|
| Crotamiton | 20 g | — |
| Liquid paraffin | 40 g | — |
| Cetomacrogol wax FTM (80:20) | 8 g | — |
| Purified water | q.s. ad 200 g | — |
Prerequisite formulations
- Κηρός FTM 80:20 / FTM wax 80:20
Documentation
Preparation description
Emulsion: Crotamiton Emulsion 10% w/w. Additional appearance criteria are not established by the specific text reviewed. [1]
Action and use
Topical treatment of scabies in hairy areas according to FTM 2010. [1]
Specifications
FTM 2010 general active-content range: 90–110% of declared amount unless specifically excepted (PDF p.15). Dosage-form requirements also apply. [1]
Light
Finished-product photostability is not specified. Any required container light protection is stated under Storage. [1]
Air and oxidation
No oxidative stability study of the finished mixture or inert-atmosphere requirement is provided. Use the source container. [1]
Water and solubility
Liquid Paraffin: JP classifies the corresponding pure raw material as practically insoluble in water. [3]
Humidity
No numerical relative-humidity limit is given for the finished product. Prevent raw-material wetting and condensation entering the container. [1]
Temperature
For the finished product the source specifies:
300 mL amber glass bottle; 15–25 °C. [1]
300 mL amber glass bottle; 15–25 °C. [1]
pH and compatibility
No finished-product pH range is specified. Do not add a pH adjuster without a supported formula change. [1]
Other interactions
No complete compatibility test with added actives or alternative excipients is provided. Substitutions require separate evidence. [1]
Ingredient-specific information
Liquid Paraffin: raw-material water solubility is classified as practically insoluble by JP. [3]
Staff protection
Risk assessment
Reference batch: 200 g. First ingredient: Crotamiton, 20 g. Independently check chemical form, units and every scale conversion before weighing.
Check homogeneity, aggregates, separation and actual yield before subdivision. Packaging should allow uniform application without introducing water into the contents.
For the local assessment record quantity per preparation, work frequency, duration of open handling, potential exposure routes and effectiveness of controls. These are assessment inputs; no fictitious final risk score is assigned.
For this procedure’s heating stage, check thermometer, heating method, duration and prevention of overheating/solvent loss. Completion of mixing does not establish cooling or complete homogenisation.
Release checkpoint: sample representative locations and early/late filling; record settling or separation and redispersibility. Verify delivery of the intended amount; visual uniformity alone does not demonstrate API uniformity.
Contains cetostearyl or cetyl alcohol, which can cause local skin reactions; include components of the selected base in the assessment. [1], [7], [9], [11]
Check homogeneity, aggregates, separation and actual yield before subdivision. Packaging should allow uniform application without introducing water into the contents.
For the local assessment record quantity per preparation, work frequency, duration of open handling, potential exposure routes and effectiveness of controls. These are assessment inputs; no fictitious final risk score is assigned.
For this procedure’s heating stage, check thermometer, heating method, duration and prevention of overheating/solvent loss. Completion of mixing does not establish cooling or complete homogenisation.
Release checkpoint: sample representative locations and early/late filling; record settling or separation and redispersibility. Verify delivery of the intended amount; visual uniformity alone does not demonstrate API uniformity.
Contains cetostearyl or cetyl alcohol, which can cause local skin reactions; include components of the selected base in the assessment. [1], [7], [9], [11]
Compounding conditions
BUD rationale
FTM 2010 states 2 calendar months at 15–25 °C in the specified 300 mL amber-glass bottle for a 200 g preparation. After opening: up to 2 calendar months, always within the overall use-by date. This is a specific official historical formulary instruction, not a new experimental study. The responsible pharmacist adopts the duration only for the exact formula, process, container and storage, applying any shorter limit. No aw measurement has been made and the website does not automatically assign a batch BUD. [1], [10]
Prerequisites
FTM wax 80:20 — 80% cetostearyl alcohol/20% cetomacrogol 1000; qualified lot; do not automatically substitute anionic BP wax [1]
Equipment
Balance with suitable minimum weight, mortar/pestle or homogeniser, mixing vessels, spatulas, thermometer for heated processes and volumetric equipment for mL quantities. [1]
Compounding method
Heat crotamiton, paraffin and wax to ~70 °C. Boil about 90 g water and cool to ~70 °C. Add half to the oil phase while stirring. Transfer to bottle, shake gently 1 minute; rinse with remaining hot water and shake another minute. Make up to 200 g with freshly boiled and cooled water; cool with gentle agitation. [1]
Observations
The wax is defined exactly as 80% cetostearyl alcohol and 20% cetomacrogol 1000. Use an identified pharmaceutical grade with documented composition. An anionic emulsifying wax or another blend is not an automatic substitute. The source and formula were reverified; release always concerns the actual batch. [1], [10]
Container and packaging
300 mL amber glass bottle for a 200 g batch. [1]
Quality control
FTM 2010 general active-content range: 90–110% of declared amount unless specifically excepted (PDF p.15). Dosage-form requirements also apply.
Record the method, acceptance criterion, actual result and reviewer separately in F-005. A critical specification failure requires quarantine and investigation under SOP-015; retesting needs justification. [1], [9]
Record the method, acceptance criterion, actual result and reviewer separately in F-005. A critical specification failure requires quarantine and investigation under SOP-015; retesting needs justification. [1], [9]
Storage
Dispensing
Labelling
Crotamiton Emulsion 10% w/w
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: To be assigned after temperature and BUD evidence is established.
Shake/redisperse well before use.
Temperature for this batch BUD: ____
Contains cetostearyl or cetyl alcohol, which can cause local skin reactions; include components of the selected base in the assessment. [1], [5], [6], [11]
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: To be assigned after temperature and BUD evidence is established.
Shake/redisperse well before use.
Temperature for this batch BUD: ____
Contains cetostearyl or cetyl alcohol, which can cause local skin reactions; include components of the selected base in the assessment. [1], [5], [6], [11]
final_decision
Documented FTM reference monograph — exact composition and source duration.
The wax is defined exactly as 80% cetostearyl alcohol and 20% cetomacrogol 1000. Use an identified pharmaceutical grade with documented composition. An anionic emulsifying wax or another blend is not an automatic substitute. The source and formula were reverified; release always concerns the actual batch.
FTM 2010 states 2 calendar months at 15–25 °C in the specified 300 mL amber-glass bottle for a 200 g preparation. After opening: up to 2 calendar months, always within the overall use-by date. This is a specific official historical formulary instruction, not a new experimental study. The responsible pharmacist adopts the duration only for the exact formula, process, container and storage, applying any shorter limit. No aw measurement has been made and the website does not automatically assign a batch BUD.
Amber-glass bottle as specified by the source; 15–25 °C. Shake before use. A different temperature or container requires separate assessment. [1], [10]
The wax is defined exactly as 80% cetostearyl alcohol and 20% cetomacrogol 1000. Use an identified pharmaceutical grade with documented composition. An anionic emulsifying wax or another blend is not an automatic substitute. The source and formula were reverified; release always concerns the actual batch.
FTM 2010 states 2 calendar months at 15–25 °C in the specified 300 mL amber-glass bottle for a 200 g preparation. After opening: up to 2 calendar months, always within the overall use-by date. This is a specific official historical formulary instruction, not a new experimental study. The responsible pharmacist adopts the duration only for the exact formula, process, container and storage, applying any shorter limit. No aw measurement has been made and the website does not automatically assign a batch BUD.
Amber-glass bottle as specified by the source; 15–25 °C. Shake before use. A different temperature or container requires separate assessment. [1], [10]
Independent Greek/English adaptation and organisation of facts from the cited source. This is not an official translation or publisher endorsement.
Sources and references
- Formulaire Thérapeutique Magistral 2010 — D-I-4-b-22010PDF pp. 267–268master formula2026-10-14
- PN/L/PG/002/00 INDUMENTARIAΔιαθέσιμο κείμενο / Retrieved textPDF pp. 1–5general staff protection2026-09-10
- MHLW — Japanese Pharmacopoeia XVIII: Liquid ParaffinJP XVIII, 2021; English textPrinted p. 1477; Description; Containers and storageraw-material monograph2026-09-12
- ASHP — USP <795> Key Changes2023pp. 1–3: scope, water activity and staff precautionsprofessional guidance; not the licensed USP chapter2026-09-12
- Texas State Board of Pharmacy — adopted 22 TAC §291.131, nonsterile compoundingTexas Register, 7 June 2024Beyond-use dating: aw categories, 14/35/90/180 days, limits and extensionspublic regulatory implementation of USP <795> BUD framework; not Greek law2026-09-12
- Illinois IDFPR — Nonsterile Compounding Self-Inspection ReportPublic checklist, retrieved 12 September 2026pp. 15–16, Establishing beyond-use datesPublic regulatory implementation of USP <795>; not Greek law; general limits and requirements for extension2026-09-12
- NIOSH — Managing Hazardous Drug Exposures: Information for Healthcare Settings2023; DHHS (NIOSH) 2023-130Risk assessment; printed pp. 27–33, activity/formulation control tableWorkplace exposure, hierarchy of controls and activity-specific PPE; US government public-domain document2026-09-12
- USP — Compounding Standards and Beyond-Use Dates, 2022 updateNovember 2022, published by USP; public copy hosted by Mississippi Boardpp. 1–2; nonsterile tableRisk-based default categories; not product-specific stability or Greek law2026-09-12
- PIC/S — Guide to Good Practices for the Preparation of Medicinal Products in Healthcare EstablishmentsPE 010-4, 1 March 2014Chapters 1–9; Annex 2 (nonsterile liquids, creams, ointments)Professional quality-system framework; not automatic national legal adoption or certification2026-09-12
- USP — General Chapter <795> FAQsUpdated 1 November 2023Questions 52, 54–56, 60–62; PDF pp. 11–14Primary clarification of aw classification, extension prerequisites and compounded-component BUDs; not automatic Greek legal adoption2026-10-14
- EMA — Excipients in the labelling and package leaflet, Annex Revision 5Published 5 December 2025EN and EL worksheets: arachis oil, wool fat, cetostearyl/cetyl alcohol, chlorocresolCurrent primary excipient warnings; used as a scientific labelling reference, without claiming MAH obligations automatically apply to a compounded prescription2026-10-14