REFERENCE FORMULA
Reference formula
Reference basis: 100 g
| Ingredient | Source quantity | Scaled quantity |
|---|---|---|
| Hydrocortisone acetate | 0.5 g | — |
| Phenol | 0.5 g | — |
| Racemic menthol | 0.2 g | — |
| Zinc oxide | 2 g | — |
| Propylene glycol | q.s. g | — |
| Nonionic O/W emulsion 2 EX011 | q.s. ad 100 g | — |
REFERENCE FORMULA SCALING
Proportional quantities of the same formula
Arithmetic aid. It does not change strength, dose, method or BUD and does not authorise compounding.
Theoretical calculation sheet
CGR-ES-070 · Hydrocortisone acetate 0.5%, phenol 0.5%, menthol 0.2% and zinc oxide 2% cream
Not an approved master record or batch release. BUD is not calculated.
| Ingredient | Reference | Calculated | Lot | Actual quantity |
|---|
Prerequisite formulations
No separate prerequisite monograph is listed.
Documentation
Preparation description
White, glossy, semisolid cream containing dispersed solids. [1]
Action and use
AEMPS describes symptomatic topical treatment of inflammatory or allergic itchy skin lesions, combining a corticosteroid, antipruritic ingredients and protective zinc oxide. [1]
Specifications
White, glossy, semisolid cream containing dispersed solids. Quantities/raw-material quality follow §3. No specific numerical finished-product assay limit is provided. [1]
Light
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
Racemic menthol is practically insoluble in water and very soluble in ethanol under PA021.
ZnO: practically insoluble in water and ethanol.
Menthol: practically insoluble in water, readily soluble in fixed oils and liquid paraffin, very slightly soluble in glycerol.
Propylene Glycol: JP classifies the corresponding pure raw material as miscible in water.
Hydrocortisone Acetate: JP classifies the corresponding pure raw material as practically insoluble in water. [4], [5], [9], [10]
ZnO: practically insoluble in water and ethanol.
Menthol: practically insoluble in water, readily soluble in fixed oils and liquid paraffin, very slightly soluble in glycerol.
Propylene Glycol: JP classifies the corresponding pure raw material as miscible in water.
Hydrocortisone Acetate: JP classifies the corresponding pure raw material as practically insoluble in water. [4], [5], [9], [10]
Humidity
Temperature
pH and compatibility
ZnO dissolves in dilute mineral acids and forms soaps with fatty acids. [4]
Other interactions
Menthol forms eutectic mixtures with camphor/thymol; incompatible with strong oxidants. [5]
Ingredient-specific information
Exact identities: Οξική υδροκορτιζόνη / Hydrocortisone acetate; Φαινόλη / Phenol; Ρακεμική μενθόλη / Racemic menthol; Οξείδιο ψευδαργύρου / Zinc oxide; Προπυλενογλυκόλη / Propylene glycol; Μη ιονικό γαλάκτωμα O/W 2 EX011 / Nonionic O/W emulsion 2 EX011. 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.
Zinc oxide: light, white to slightly yellowish, amorphous powder without aggregates. Dilute mineral acids dissolve it; fatty acids in a base can form zinc salts.
Propylene glycol (1,2-propanediol): colourless viscous water-miscible cosolvent and humectant. A small amount does not establish adequate preservation.
Propylene Glycol: raw-material water solubility is classified as miscible by JP.
Hydrocortisone Acetate: raw-material water solubility is classified as practically insoluble by JP.
Propylene glycol: retain original manufacturer, lot and reliable certificate. For the applicable raw materials, FDA describes DEG and EG testing, each limited to 0.10% under the relevant monograph. This is a raw-material limit. [1], [4], [8], [9], [10], [11]
Zinc oxide: light, white to slightly yellowish, amorphous powder without aggregates. Dilute mineral acids dissolve it; fatty acids in a base can form zinc salts.
Propylene glycol (1,2-propanediol): colourless viscous water-miscible cosolvent and humectant. A small amount does not establish adequate preservation.
Propylene Glycol: raw-material water solubility is classified as miscible by JP.
Hydrocortisone Acetate: raw-material water solubility is classified as practically insoluble by JP.
Propylene glycol: retain original manufacturer, lot and reliable certificate. For the applicable raw materials, FDA describes DEG and EG testing, each limited to 0.10% under the relevant monograph. This is a raw-material limit. [1], [4], [8], [9], [10], [11]
Compounding conditions
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.
For topical preparations, incorporate hydrocortisone acetate cold, dissolved or finely powdered, into the prepared base. [2], [7]
For topical preparations, incorporate hydrocortisone acetate cold, dissolved or finely powdered, into the prepared base. [2], [7]
Staff protection
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.
Phenol: prevent skin/eye contact, select gloves using the SDS and provide prompt eyewash access.
Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage.
Contain powder during weighing and trituration and use eye protection; select respiratory protection for the actual exposure. [3], [5], [6], [12]
Menthol: eye protection and prevention of contact/dust inhalation.
Phenol: prevent skin/eye contact, select gloves using the SDS and provide prompt eyewash access.
Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage.
Contain powder during weighing and trituration and use eye protection; select respiratory protection for the actual exposure. [3], [5], [6], [12]
Risk assessment
Corticosteroid: systemic absorption risk with extensive, prolonged or occluded application. Phenol requires specific staff-exposure control.
Phenol: skin absorption, burns and systemic toxicity.
Menthol: prevent contact with nasal mucosa in small children; laryngeal spasm and collapse have been reported below age 2. Avoid open wounds and mucosa.
Propylene glycol: assess exposure from all medicines, especially in neonates, children under 5 and renal/hepatic impairment. For oral dosing: mg/kg/day = mg/mL × daily mL ÷ body weight in kg.
Reference batch: 100 g. First ingredient: Hydrocortisone acetate, 0.5 g. Independently check chemical form, units and every scale conversion before weighing.
Check addition order, phase-temperature difference and uniformity after cooling. Phase separation can alter local strength and preservative partitioning; do not repair it arbitrarily with water or emulsifier.
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.
Release checkpoint: inspect aggregates, crystals, local texture differences and free liquid after completing the method. Record mixing geometry, batch size and actual temperatures; copying rpm to another mixer does not establish process equivalence. [1], [5], [6], [8], [15], [17]
Phenol: skin absorption, burns and systemic toxicity.
Menthol: prevent contact with nasal mucosa in small children; laryngeal spasm and collapse have been reported below age 2. Avoid open wounds and mucosa.
Propylene glycol: assess exposure from all medicines, especially in neonates, children under 5 and renal/hepatic impairment. For oral dosing: mg/kg/day = mg/mL × daily mL ÷ body weight in kg.
Reference batch: 100 g. First ingredient: Hydrocortisone acetate, 0.5 g. Independently check chemical form, units and every scale conversion before weighing.
Check addition order, phase-temperature difference and uniformity after cooling. Phase separation can alter local strength and preservative partitioning; do not repair it arbitrarily with water or emulsifier.
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.
Release checkpoint: inspect aggregates, crystals, local texture differences and free liquid after completing the method. Record mixing geometry, batch size and actual temperatures; copying rpm to another mixer does not establish process equivalence. [1], [5], [6], [8], [15], [17]
BUD rationale
Period reported by source: The specific monograph states 3 months, only if preserved 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.
This duration is a specific formulary/source instruction. This review did not verify a complete primary study establishing chemical, physical and microbiological extension for the same finished formulation.
Selected general rule: up to 35 days for an aqueous form appropriately preserved in its final composition and pH. Use 20–25 °C, or 2–8 °C only where permitted/required by the source and compatible with the dosage form. A preservative name is insufficient if it is diluted, inactivated or partitioned into another phase.
The reference-policy ceiling in this edition is the shorter of the source period above and the general ceiling. Extension needs matching active/excipients/strength, container, temperature, a stability-indicating method and the required microbiological evidence for aqueous extension. An applicable official USP–NF compounded monograph is assessed separately in its complete text.
Use-by date = the earliest allowed date from preparation plus selected period, ingredient expiries and any shorter supported limit. In-use dating never extends overall BUD. Complete the actual date for the batch after the required checks.
A default is a conservative dating limit, not experimental proof of batch stability. Its category depends on final composition, preservation and permitted temperatures. Water percentage or loss on drying does not determine aw. Document using SOP-014/F-006; use SOP-017/F-012 for specific aw evidence.
USP does not require water-activity measurement for every nonsterile preparation. A justified classification of the actual formulation may guide dating; record it explicitly as inferred, not measured. Uncertain or borderline classification requires specific evidence or a suitable measurement. Finished-product dating does not outlast the available dating of previously compounded components/bases unless adequate specific evidence for the exact finished preparation has been formally adopted. [1], [13], [14], [16], [18]
This duration is a specific formulary/source instruction. This review did not verify a complete primary study establishing chemical, physical and microbiological extension for the same finished formulation.
Selected general rule: up to 35 days for an aqueous form appropriately preserved in its final composition and pH. Use 20–25 °C, or 2–8 °C only where permitted/required by the source and compatible with the dosage form. A preservative name is insufficient if it is diluted, inactivated or partitioned into another phase.
The reference-policy ceiling in this edition is the shorter of the source period above and the general ceiling. Extension needs matching active/excipients/strength, container, temperature, a stability-indicating method and the required microbiological evidence for aqueous extension. An applicable official USP–NF compounded monograph is assessed separately in its complete text.
Use-by date = the earliest allowed date from preparation plus selected period, ingredient expiries and any shorter supported limit. In-use dating never extends overall BUD. Complete the actual date for the batch after the required checks.
A default is a conservative dating limit, not experimental proof of batch stability. Its category depends on final composition, preservation and permitted temperatures. Water percentage or loss on drying does not determine aw. Document using SOP-014/F-006; use SOP-017/F-012 for specific aw evidence.
USP does not require water-activity measurement for every nonsterile preparation. A justified classification of the actual formulation may guide dating; record it explicitly as inferred, not measured. Uncertain or borderline classification requires specific evidence or a suitable measurement. Finished-product dating does not outlast the available dating of previously compounded components/bases unless adequate specific evidence for the exact finished preparation has been formally adopted. [1], [13], [14], [16], [18]
Prerequisites
No separately registered base is required. Any commercial vehicle remains the exact named product in the formula table. [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
1. Prepare and check EX011 and let it cool.
2. Finely triturate and mix the actives in a mortar.
3. Levigate with the minimum necessary propylene glycol.
4. Gradually incorporate the cooled base and homogenise with a spatula to a final mass of 100 g. Propylene glycol is included in the final mass. [1], [2]
2. Finely triturate and mix the actives in a mortar.
3. Levigate with the minimum necessary propylene glycol.
4. Gradually incorporate the cooled base and homogenise with a spatula to a final mass of 100 g. Propylene glycol is included in the final mass. [1], [2]
Observations
The professional text gives 2–3 applications/day for adults and children over 12, while the leaflet gives 3. The label leaves patient-specific dosing blank. [1]
Container and packaging
PVC cream jar with an inner closure or tamper-evident cap, as specified by the source. [1]
Labelling
Hydrocortisone acetate 0.5%, phenol 0.5%, menthol 0.2% and zinc oxide 2% cream
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Below 30°C, tightly closed and protected from light.
Temperature for this batch BUD: ____ [1]
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Below 30°C, tightly closed and protected from light.
Temperature for this batch BUD: ____ [1]
Quality control
Under AEMPS: organoleptic properties and final mass. Batch production additionally requires spreadability PN/L/CP/003/00, emulsion type PN/L/CP/002/00, pH for O/W under PN/L/CP/001/00 and microbiological testing under RFE 5.1.4. No formula-specific active-assay or pH limits are specified here; local release criteria are required.
Polyol incoming QC: pharmacies test each lot or ensure documented testing by a reliable supplier, as described by FDA. IR identity alone does not exclude DEG/EG.
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], [2], [11], [17]
Polyol incoming QC: pharmacies test each lot or ensure documented testing by a reliable supplier, as described by FDA. IR identity alone does not exclude DEG/EG.
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], [2], [11], [17]
Storage
Below 30°C, tightly closed and protected from light. [1]
Dispensing
Cutaneous use only. Avoid eyes, mucosa, eroded skin and active uncontrolled infection. Children require medical supervision. Exercise caution in pregnancy, breastfeeding and use over large areas. Finalise dosing in the prescription. [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.
Independent Greek/English adaptation and organisation of facts from the cited source. This is not an official translation or publisher endorsement.
Sources and references
- FN/2003/FMT/002 ACETATO DE HIDROCORTISONA Y FENOL, CREMA DEFN/2003/FMT/002Master formula §§3–4; packaging/storage §5; description §6; period §7; use/precautions §§8–12 and patient leafletspecific formulation2026-09-10
- PN/L/FF/002/00 ELABORACIÓN DE EMULSIONESPN/L/FF/002/00§4.3 environment; §4.4 method; §4.6 controlsgeneral procedure2026-09-10
- PN/L/PG/002/00 INDUMENTARIAPN/L/PG/002/00Clothing and protective equipmentgeneral procedure2026-09-10
- FN/2003/PA/028 ÓXIDO DE ZINCFN/2003/PA/028Raw-material properties, handling and incompatibilitiesraw material2026-09-10
- FN/2003/PA/021 MENTOL RACÉMICOFN/2003/PA/021Raw-material properties, handling and incompatibilitiesraw material2026-09-10
- CDC/NIOSH — Pocket Guide to Chemical Hazards: PhenolOfficial agency pageRaw-material properties, handling and incompatibilitiesspecific formulation2026-09-10
- FN/2003/PA/015 HIDROCORTISONA, ACETATO DEFN/2003/PA/015Raw-material properties, handling and incompatibilitiesraw material2026-09-10
- EMA — Questions and answers on propylene glycol used as an excipient, EMA/CHMP/704195/20139 October 2017Sections 1–3 and annexingredient facts2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: Propylene GlycolJP XVIII, 2021; English textPrinted p. 1600; Description; Containers and storageraw-material monograph2026-09-12
- MHLW — Japanese Pharmacopoeia XVIII: Hydrocortisone AcetateJP XVIII, 2021; English textPrinted p. 1114; Description; Containers and storageraw-material monograph2026-09-12
- FDA — Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High-Risk Drug Components for Diethylene Glycol and Ethylene GlycolMay 2023, revision 1Recommendations; section on pharmacy compoundingraw material quality2026-09-12
- 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> FAQs (official, updated 1 November 2023)Updated 1 November 2023; retrieved 14 October 2026Q52, Q61–64; use with the applicable full chapterWater-activity classification, component dating and BUD documentation; general professional framework, not a Greek legal adoption or formula-specific study2026-10-14