Hydrocortisone acetate 0.5%, phenol 0.5%, menthol 0.2% and zinc oxide 2% cream

White, glossy, semisolid cream containing dispersed solids.

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AEMPS describes symptomatic topical treatment of inflammatory or allergic itchy skin lesions, combining a corticosteroid, antipruritic ingredients and protective zinc oxide.

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White, glossy, semisolid cream containing dispersed solids. Quantities/raw-material quality follow §3. No specific numerical finished-product assay limit is provided.

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The finished preparation is stored protected from light under the monograph.

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No specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.

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ZnO: practically insoluble in water and ethanol.
Racemic menthol is practically insoluble in water and very soluble in ethanol under PA021.

References: [4] · [5]

PA015 requires low humidity and cold incorporation of hydrocortisone acetate into topical bases; no numerical humidity limit is given.

References: [7]

Finished-product storage: Below 30°C, tightly closed and protected from light. Processing follows the method-specific temperatures.

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ZnO dissolves in dilute mineral acids and forms soaps with fatty acids.

References: [4]

Menthol forms eutectic mixtures with camphor/thymol; incompatible with strong oxidants.

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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.

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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.

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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.

References: [3] · [5] · [6]

Corticosteroid: systemic absorption risk with extensive, prolonged or occluded application. Phenol requires specific staff-exposure control.
Phenol: skin absorption, burns and systemic toxicity.

References: [1] · [6]

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.

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CGR-ES-020 — Μη ιονικό γαλάκτωμα O/W 2 — EX011 / Nonionic O/W Emulsion 2 EX011
Referenced bases are included in the package; also check their dependencies.

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

References: [1] · [8]

Balance with suitable resolution, mortar/spatula, suitable mixing vessels and final container. Add volumetric equipment for mL, a controlled water bath where melting is specified and a suitable filter where required. Analytical equipment follows the QC methods.

References: [2]

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.

References: [1] · [2]

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.

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PVC cream jar with an inner closure or tamper-evident cap, as specified by the source.

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Hydrocortisone acetate 0.5%, phenol 0.5%, menthol 0.2% and zinc oxide 2% cream
Quantity: _____ · Batch: _____ · Prepared: _____ · Use by: _____
External use only. Storage: Below 30°C, tightly closed and protected from light.
Patient/directions or laboratory use: _____ · Pharmacy/telephone: _____
Specimen for pharmacist adaptation; not a final approved label.

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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.

References: [1] · [2]

Below 30°C, tightly closed and protected from light.

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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.

References: [1]