Salicylic acid 5% w/w ointment with 3% liquid paraffin · CGR-ES-101 (CGR-ES-101)

REFERENCE FORMULA

Reference formula

Reference basis: 100 g τελικής αλοιφής / final ointment

Ingredient	Source quantity	Scaled quantity
Salicylic acid	5 g	—
Liquid paraffin	3 g	—
White soft paraffin	q.s. ad 100 g	—

Prerequisite formulations

No separate prerequisite monograph is listed.

Documentation

Preparation description

Ointment with no added water, containing 5 g salicylic acid and 3 g liquid paraffin per 100 g. The drug is finely dispersed in the greasy base; it is not assumed fully dissolved. The source describes a uniform white to yellowish-white ointment without detectable crystals. ^[1]

Action and use

Topical keratolytic for appropriately diagnosed hyperkeratotic/scaling lesions. This sheet fixes strength at 5%; other literature concentrations are not generalised. Do not apply to an undiagnosed pigmented lesion, infected/eroded skin, face or mucosa. ^[1]

Specifications

Nominal strength is 50 mg/g. Source: uniform white/yellowish ointment without detectable crystals. No numerical particle-size limit, assay acceptance range or aw is given. Absence of grittiness is a physical-quality check, not analytical proof of potency. ^{[1], [4]}

Light

The source requires protection from light. Select suitable opaque packaging/secondary protection without adding an antioxidant. No specific photodegradation rate is assigned to this greasy formulation. ^[1]

Air and oxidation

Keep tightly closed and limit open mixing after completion. No evidence requires nitrogen or an antioxidant. Do not return removed material to the container. ^{[1], [4]}

Water and solubility

No water is added. Use dry equipment and a clean dry spatula; water ingress changes the preparation and microbiological assessment. Salicylic acid’s low water solubility does not justify an improvised water-dissolution step [2]. ^{[1], [2], [4]}

Humidity

No relative-humidity limit is stated. Tight closure and dry equipment prevent contamination/moisture ingress. No measured aw<0.60 is claimed merely because water is not added. ^{[1], [4]}

Temperature

Store below 30 °C and protected from light [1]. The specified mortar dispersion does not require melting. Heating that temporarily dissolves crystals may alter subsequent particle distribution and is not introduced without assessment. Avoid flames/hot surfaces when handling powder [2]. ^{[1], [2]}

pH and compatibility

Direct aqueous pH measurement does not apply to this paraffin ointment. The source specifies neither pH nor an aqueous-extract method. Do not add alkali for “correction”, since that would alter the acid and composition. ^[1]

Other interactions

Avoid concurrent exfoliating/irritating products or salicylates on the same area without medical direction [1]. Segregate salicylic-acid raw material from strong oxidants and incompatible metals under its safety card [2]. Do not add other APIs to the finished base without reassessment. ^{[1], [2]}

Ingredient-specific information

Use salicylic acid CAS 69-72-7/RFE 0366, not acetylsalicylic acid. Liquid paraffin RFE 0239 is the levigating fluid. The remainder, theoretically 92 g per 100 g without losses, is white soft paraffin. Yellow petrolatum/another base is not an automatic substitute. ^{[1], [2]}

Staff protection

During grinding, contain dust with closed/controlled handling, gloves, protective clothing and eye protection. ICSC identifies serious eye injury and suspected reproductive toxicity for the raw material [2]. Local assessment selects extraction/respiratory protection; do not automatically transfer neat-API classification to the finished ointment. ^{[2], [4]}

Risk assessment

Risks include agglomerates/nonuniformity, wrong strength and increased systemic uptake over large areas, damaged skin or occlusion. Review children, renal/hepatic impairment, diabetes/poor circulation and pregnancy particularly carefully [1,2]. Avoid occlusion without direction. Paraffin residue on clothing/dressings accelerates ignition; no smoking or naked flames [3]. ^{[1], [2], [3], [4]}

Compounding conditions

For M g finished product:0.05 M g acid,0.03 M g liquid paraffin and white soft paraffin to M g. Independently verify proportions, use clean dry equipment and weigh final yield. Do not replace liquid paraffin with another solvent or add water to remove grittiness. ^{[1], [4]}

BUD rationale

Source:3 months below 30 °C, protected from light and tightly closed [1]. No full primary study matching exactly 5% acid/3% liquid paraffin/white soft paraffin with the chosen container was identified. Select a reference ceiling of 89 days and never beyond 3 calendar months, conditional on documented local adoption of process, packaging and controls [4]. This is not measured aw or general 180-day stability evidence. Earlier material expiry and physical failure prevail. 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], [4]}

Prerequisites

There is no composite-base dependency. Use exactly the three specified raw materials. French CGR-FR-019 without the additional liquid paraffin is not the same composition; this is a defined paraffin variant, not a new active substance. ^[1]

Equipment

Glass mortar/pestle, suitable balance, spatulas, a surface for assessing fine dispersion and ointment packaging. Use particle-examination equipment where specified locally; no arbitrary micrometre limit is introduced. ^{[1], [4]}

Compounding method

1. Finely grind salicylic acid in a glass mortar with dust control. 2. Levigate with 3 g liquid paraffin. 3. Progressively incorporate white soft paraffin by geometric mixing to uniformity and final 100 g. 4. Check grittiness/dispersion, final mass and package. ^{[1], [4]}

Observations

5% w/w means 50 mg/g. The source’s “no crystals” requirement is applied to absence of detectable coarse crystals/agglomerates; it does not prove molecular dissolution of all acid. Mortar losses are documented as yield, not compensated by an arbitrary API increase. ^{[1], [4]}

Container and packaging

Use a suitable tightly closed light-protective ointment container. Prefer a system limiting finger/water contact; verify inner-surface and closure compatibility for an acidic greasy dispersion. Include the fabric/flame warning on packaging. ^{[1], [3], [4]}

Quality control

Check weights, final yield, colour and uniform distribution; inspect a thin smear for grittiness/visible crystals. The local plan may include microscopy and assay. Do not mark a batch suitable without its results and pharmacist release. ^{[1], [4]}

Storage

Below 30 °C, protected from light, tightly closed and protected from water ingress. Keep away from children. Avoid flames/smoking near clothing or bedding with product residue, including after ordinary washing [3]. ^{[1], [3]}

Dispensing

Specify application area/duration individually; avoid indiscriminate large-area use. The source excludes children under 2 years; older children and vulnerable patients require review. Avoid mucosa/eyes, wounds and occlusion. Counsel about irritation, systemic salicylate symptoms and fabric fire risk. ^{[1], [2], [3]}

Labelling

Salicylic acid 5% w/w — OINTMENT. External use only. Area/directions: __. Avoid eyes, mucosa and wounds; no occlusion without direction. Below 30 °C, protected from light, tightly closed. Keep away from children. No smoking/naked flames near contaminated fabrics. Batch: __. Prepared: __. Use by: __. compounding.gr. ^{[1], [3], [4]}

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

AEMPS — Formulario Nacional: VASELINA SALICÍLICAFN/2003/PO/032; current standalone PDFPDF p.2 formula/method/container/BUD; subsequent patient and safety sectionsMaster formula; independently adapted, not an official translation2026-10-14
ILO/WHO — ICSC0563 Salicylic acidNovember 2023Handling, classification, chemical properties and exposure effectsRaw salicylic acid powder hazards; not finished 5% mixture classification or BUD2026-10-13
MHRA — Emollients: risk of severe and fatal burns18 December 2018; clarification 26 August 2020Advice for healthcare professionals; mechanism of riskFabric-residue ignition risk, including paraffin-containing preparations; not finished-product flash-point measurement2026-10-13
Ministerio de Sanidad — Guía de buenas prácticas de preparación de medicamentos en servicios de farmacia hospitalariaJune 2014; official AEMPS copyAnnexes 3–4, PDF pp.51–58Nonsterile preparation risk assessment, equipment, packaging and quality controls; not Greek legislation2026-10-13
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