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CGR-ES-082 / EDITION 10.0

Erythromycin 2% cream

Oil-in-water cream for cutaneous use · 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 finished cream;2% w/w

IngredientSource quantityScaled quantity
Erythromycin2 g—
Ethanol 96%q.s. βλ. διαδικασία / see method—
Nonionic O/W emulsion 1, EX010q.s. ad 100 g—

Prerequisite formulations

Documentation

Preparation description
White, firm cream containing 20 mg erythromycin per g. This specific nonionic O/W emulsion is not interchangeable with any commercial erythromycin gel. [1]
Action and use
Source describes topical acne treatment. Current NICE guidance advises against topical-antibiotic monotherapy; use requires a prescribed overall regimen and review of resistance/response rather than indefinite repeat supply. [1], [3]
Specifications
White firm homogeneous cream without phase separation or visible crystals; final mass 100 g. FN supplies no numeric finished pH, viscosity or assay limits. [1]
Light
Protect in opaque packaging. Storage data for a commercial alcoholic gel are not transferred to this cream. [1]
Air and oxidation
Keep base and alcoholic solution covered between operations. Limit aeration/foam and ethanol loss that may change dispersion or promote crystallisation. [1], [2], [5]
Water and solubility
Base has an external aqueous phase containing preserved water EX001. Do not dilute finished cream with water or substitute water for the small ethanol quantity used to dissolve erythromycin. [1], [2], [7]
Humidity
Keep cream/base closed to limit water-content changes. No numeric laboratory relative-humidity limit is specified. [1], [2]
Temperature
EX010 base uses phases at 70–75 °C. Add erythromycin at the end, not during initial phase heating. FN gives no numeric API-incorporation temperature. Store below 30 °C. [1], [2]
pH and compatibility
No final pH range is published. Record pH using a suitable emulsion method for local trending; do not acidify or alkalinise without erythromycin/base compatibility evidence. [1], [2]
Other interactions
Concurrent peeling/irritant topical products may increase irritation. Do not add benzoyl peroxide, a retinoid or another active to this cream without a separately supported formulation. [1], [3], [4]
Ingredient-specific information
Use erythromycin base, not an ester/salt. EX010 contains nonionic self-emulsifying base 22%, virgin almond oil 3%, BHT 0.02%, propylene glycol 5% and preserved water; final proportions are altered by API/ethanol addition. Qualify the exact base grade and review allergy history. [1], [2], [4]
Staff protection
Contain antibiotic powder during weighing; use gloves, coat and eye protection. Control ethanol vapour/ignition sources and clean equipment to avoid cross-contaminating other preparations. [1], [5]
Risk assessment
Critical risks include wrong erythromycin form, unsuitable base, unrecorded ethanol quantity, API heating and antimicrobial resistance. Allergy/severe irritation requires stopping and assessment. Erythromycin is not demonstrated batch preservation. [1], [3], [4]
Compounding conditions
Use homogeneous EX010 with documented remaining dating. Record exact ethanol needed to dissolve 2 g erythromycin; make up with base to 100 g, rather than adding 2 g to 100 g preweighed base. [1], [2]
BUD rationale
AEMPS states 3 months below 30 °C, protected from light. This sheet chooses a conservative 35-day ceiling at 20–25 °C under the general preserved-aqueous framework, not demonstrated stability. Base must retain the exact EX001 preservative system. No independent study of this cream, aw or final-product AET was retrieved; antibiotic activity does not substitute for them. Earlier base/ingredient dating controls. 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], [6], [7]
Prerequisites
EX010→CGR-ES-019; its preserved water EX001→CGR-ES-018. The nonionic self-emulsifier must match the qualified base, not any generic cream vehicle. [1], [2], [7]
Equipment
Balance, ethanol-dissolution vessel, cream-appropriate mixing equipment and filling tools. Base manufacture additionally requires controlled water bath and thermometer. [1], [2]
Compounding method
Prepare EX010 by its defined base procedure. Dissolve 2 g erythromycin in a small measured quantity of ethanol 96%. At the final stage gradually incorporate into the cream with gentle mixing, then make up to 100 g using the same base. Homogenise without aeration and inspect for separation/crystals before filling. [1], [2]
Observations
Source provides no maximum ethanol amount; recording and reproducing the qualified local process is essential. A 2% strength does not establish equivalence to 2% alcoholic gel. [1], [4]
Container and packaging
Use compatible opaque packaging with effective closure. Tube or narrow-opening pack may reduce handling contamination after compatibility qualification; source itself specifies an opaque container. [1]
Quality control
Independently verify 20 mg/g, final mass, uniformity and absence of grittiness/separation. Record pH/rheology as local comparisons. Erythromycin assay and microbial quality require suitable validated methods. [1], [2]
Storage
Store 20–25 °C and always below 30 °C, closed and light-protected. Freeze tolerance or a different vehicle is not established. [1], [6]
Dispensing
Use only on prescribed skin sites, avoiding eyes/mucosa. Provide a written regimen and clinical review date. Do not present as indefinite prophylactic antibiotic use or as acne therapy without an overall treatment plan. [1], [3]
Labelling
Erythromycin 2% (20 mg/g) cream · FOR SKIN USE. Directions__. Store 20–25 °C, light-protected and closed. Keep away from children. Batch__/Prepared__/Use by__. [1], [6]
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 — FN/2003/FMT/007 ERITROMICINA, CREMA DECurrent AEMPS standalone PDF; code FN/2003/FMT/007PDF p 2 §§3–7; subsequent safety and patient informationExact formulation, process, source shelf life and formulation-specific precautions; independent factual compilation, not official translation.2026-10-14
  2. AEMPS — Formulario Nacional — FN/2003/EX/010 EMULSIÓN O/A NO IÓNICA 1Current AEMPS standalone PDF; code FN/2003/EX/010PDF p 2 §§3–7; subsequent safety and patient informationExact formulation, process, source shelf life and formulation-specific precautions; independent factual compilation, not official translation.2026-10-13
  3. NICE NG 198 — Acne vulgaris: managementCurrent recommendation retrieved 13 October 2026Recommendation 1.5.11; rationale on antibiotic monotherapyOfficial clinical guideline: avoid antibiotic monotherapy for acne; no formulation or stability claim. Indexed official recommendation and rationale retrieved; direct page access intermittently 403.2026-10-13
  4. DailyMed — ERYGEL erythromycin topical gel 2% labelLabel revisedJune 2018; listing marketing end 30 September 2025; retrieved 13 October 2026Description, contraindications, warnings, precautionsPrimary archived product label supporting erythromycin identity/solubility and topical safety, not evidence of current marketing or this cream BUD.2026-10-13
  5. CDC/NIOSH Pocket Guide — Ethyl alcoholPage reviewed 30 October 2019; retrieved 13 October 2026Flammability, incompatibilities and personal protectionEthanol raw-material handling; not a measured flash point or hazard classification of the finished mixture.2026-10-13
  6. USP — Compounding Standards and Beyond-Use DatesNovember 2022 USP publication, public copy hosted by Mississippi Boardp 2 nonsterile comparison tableGeneral category limits only; not product-specific stability, antimicrobial effectiveness or Greek law.2026-10-13
  7. AEMPS — Formulario Nacional — FN/2003/EX/001 AGUA CONSERVANTECurrent AEMPS standalone PDF; code FN/2003/EX/001PDF p 2 §§3–7; subsequent safety and patient informationExact formulation, process, source shelf life and formulation-specific precautions; independent factual compilation, not official translation.2026-10-14
  8. 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