REFERENCE FORMULA
Reference formula
Reference basis: 100 g τελικού προϊόντος /100 g final product
| Ingredient | Source quantity | Scaled quantity |
|---|---|---|
| Boric acid | 10 g | — |
| White soft paraffin (petrolatum) | q.s. ad 100 g | — |
Prerequisite formulations
No separate prerequisite monograph is listed.
Documentation
Preparation description
White, glossy, greasy, odourless ointment containing 100 mg boric acid per g. The solid drug is uniformly incorporated into white soft paraffin; no water is added. [1]
Action and use
Specifications
Strength 10% w/w, final mass 100 g; petrolatum 90 g before losses. The source specifies a white glossy odourless ointment. Check uniform dispersion without palpable crystals or aggregates. Numerical particle-size and finished-assay limits are not supplied. [1]
Light
Protect from light using an opaque jar or tube kept closed. No permissible light-exposure period is defined. [1]
Air and oxidation
Close promptly after withdrawal. Use a clean spatula and do not return removed material, limiting contamination. No inert atmosphere is required. [1]
Water and solubility
No water is added; do not replace petrolatum with an aqueous cream. Use dry equipment and prevent water ingress. Finished-product aw has not been measured. [1]
Humidity
No room-humidity limit is supplied. Keep the powder closed and equipment dry; investigate unexpected raw-material agglomeration before use. [1]
Temperature
Store below 25 °C. Preparation uses mechanical incorporation without a melting step. Avoid arbitrary heating that changes rheology and may produce nonuniformity on cooling. [1]
pH and compatibility
pH is not directly defined for this nonaqueous ointment. Do not infer a numerical pH from raw-material acidity; any extract test requires a separate method and limit. [1]
Other interactions
Ingredient-specific information
Staff protection
Weigh powder under local extraction with gloves, coat and eye protection. Boric acid has reproductive hazards; minimise inhalation and surface contamination and follow the SDS for waste handling. [3]
Risk assessment
Compounding conditions
Before preparation document indication and permitted area/duration. For final massM g: boric acid 0.10 M g, petrolatum toM g. Do not compensate losses by adding vehicle alone. [1]
BUD rationale
The source gives 3 months closed, protected from light, below 25 °C. Use the earlier of 89 days or 3 calendar months as a reference ceiling, conditional on local adoption of the exact formula/container/controls and earlier material expiry. No matched stability study or measured aw was identified; this is not laboratory validation. 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]
Prerequisites
No compounded base dependency. Use identified, certified boric acid and white soft paraffin. A nonionic emulsion monograph is not required. [1]
Equipment
Balance, mortar/pestle, spatula, ointment slab or suitable mixer, and dispensing container. Equipment must enable fine uniform dispersion without contamination. [1]
Compounding method
Pulverise boric acid. Incorporate into petrolatum progressively with trituration until uniformly dispersed. Verify final mass/uniformity and pack. No solvent addition or thermal sterilisation is specified. [1]
Observations
Container and packaging
Opaque tightly closed jar or tube suitable for an oleaginous ointment. Record container type/lot. A tube limits repeated direct contact but does not establish longer dating. [1]
Quality control
Check identity/certificates, independent 10% calculation, final mass, appearance, uniform distribution and absence of grittiness; check closure/label. No assay or microbial test was performed in this work. [1]
Storage
Below 25 °C, tightly closed, protected from light and away from heat. Store separately from oral products and out of children’s reach. [1]
Dispensing
Supply only after patient assessment. The source excludes children under 3, which does not automatically clear older children. Pregnancy/breastfeeding requires medical review. Explain that paraffin residue on fabrics increases burn risk; avoid smoking/open flames [4]. Contraindicated in hypersensitivity to any ingredient. [1], [2], [4]
Labelling
BORIC ACID 10% w/w — CUTANEOUS USE. Do not swallow. No wounds, mucosa or large areas. Area/duration: ___. Batch: ___. Prepared/use by: ___. Below 25 °C, closed, protect from light. Keep away from children and flames. [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.
Sources and references
- AEMPS — Formulario Nacional: VASELINA BORICADA (FN/2003/PO/030)2003 source code; current standalone PDF accessed 2026PDF pp.2–3, §§3–12 and patient leafletExact formula, process, finished appearance, source dating and route-specific precautions.2026-10-14
- EMA — Questions and answers on boric acid and borates used as excipients, Rev.1Adopted 11 November 2021; published 26 July 2022pp.3–6; §3, §5 and conversion annexBoron toxicity, age-related exposure warnings and conversion factors. Excipient guidance informs safety appraisal; not authorisation of these boron-active preparations.2026-10-13
- ILO/WHO — ICSC 0991: Boric acidApril 2014Prevention; chemical dangers; exposure effectsCAS 10043-35-3; occupational dust and reproductive hazards; raw-material precautions.2026-10-13
- MHRA — Emollients: risk of severe and fatal burns18 December 2018Advice for healthcare professionals and patientsFire risk from paraffin-containing residues on clothing, bedding and dressings.2026-10-13
- ABDA/AMK — Bedenkliche Rezepturarzneimittel, Stand Juni 20251 July 2025Recommendations; table entry Borsäure sowie deren Ester und SalzePrimary professional safety position: benefit–risk concerns and boron thresholds. German context, not Greek law and not a globally binding ban.2026-10-13
- Medsafe — Boron-containing excipients and fertility concerns, MARC 18610 June 2021pp.4–6, 14–18Regulatory evidence review and absorption uncertainty; its quoted 2017 warning wording is superseded by EMA Rev.1.2026-10-13
- 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