Salicylic acid 5% and triamcinolone acetonide 0.1% cream

White cream with a firm consistency.

References: [1]

AEMPS describes symptomatic treatment of psoriatic skin lesions. Salicylic acid is keratolytic; triamcinolone is an anti-inflammatory corticosteroid.

References: [1]

White cream with a firm consistency. Quantities/raw-material quality follow §3. No specific numerical finished-product assay limit is provided.

References: [1]

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

References: [1]

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

References: [1]

Salicylic acid is slightly soluble in water and freely soluble in ethanol under PA033.

References: [4]

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

References: [1]

Finished-product storage: Protect from light; below 30°C. Processing follows the method-specific temperatures.

References: [1]

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

References: [1]

Salicylic acid: incompatibilities with alkalis, Fe/Pb salts and iodine. Above 2%, problems may occur in nonionic emulsions.

References: [4]

Exact identities: Σαλικυλικό οξύ / Salicylic acid; Ακετονίδιο τριαμκινολόνης / Triamcinolone acetonide; Προπυλενογλυκόλη / Propylene glycol; Ανιονικό γαλάκτωμα O/W EX007 / Anionic O/W emulsion EX007. 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.

References: [1]

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.

References: [2]

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.
Salicylic acid: avoid dust, inhalation and eye/mucosal contact; use eye protection.

References: [3] · [4]

Low-concentration corticosteroid: weighing accuracy and homogeneity are critical. The source reports systemic toxicity with large areas/high doses, especially in children and renal or hepatic impairment.

References: [1]

The specific monograph states 3 months 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.

References: [1]

CGR-ES-043 — Ανιονικό γαλάκτωμα O/W EX007 / Anionic O/W emulsion EX007
Referenced bases are included in the package; also check their dependencies.

• CGR-ES-043 · Anionic O/W emulsion EX007

References: [1] · [5]

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 anionic emulsion EX007.
2. Finely triturate and mix both actives in a mortar.
3. Disperse in the minimum necessary propylene glycol to form a uniform paste.
4. Add the cooled base gradually while mixing with the pestle. Make up to a total mass of 100 g with base and homogenise.

References: [1] · [2]

The formula requires anionic base EX007. Do not arbitrarily substitute a nonionic cream, particularly with 5% salicylic acid.

References: [1]

Opaque jar or plastic tube.

References: [1]

Salicylic acid 5% and triamcinolone acetonide 0.1% cream
Quantity: _____ · Batch: _____ · Prepared: _____ · Use by: _____
External use only. Storage: Protect from light; below 30°C.
Patient/directions or laboratory use: _____ · Pharmacy/telephone: _____
Specimen for pharmacist adaptation; not a final approved label.

References: [1]

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]

Protect from light; below 30°C.

References: [1]

The source gives 1–3 applications/day to clean, dry affected skin. Do not use under age 2, with salicylate/corticosteroid allergy, on mucosa or eroded skin. No occlusion without medical direction. Avoid extensive/prolonged use and combination with other keratolytics.

References: [1]