Racemic camphor 10% w/w ointment with white beeswax 8% w/w · CGR-ES-096 (CGR-ES-096)

REFERENCE FORMULA

Reference formula

Reference basis: 100 g / 100 g

Ingredient	Source quantity	Scaled quantity
Racemic camphor	10 g	—
White beeswax	8 g	—
White soft paraffin	q.s. ad 100 g	—

Prerequisite formulations

No separate prerequisite monograph is listed.

Documentation

Preparation description

White firm ointment with characteristic camphor odour. Per 100 g it contains 10 g racemic camphor, 8 g white beeswax and theoretically 82 g white soft paraffin. No water is added. ^{[1], [2]}

Action and use

The source describes symptomatic relief of myalgia/arthralgia associated with bruises, sprains or contractures. Apply a thin layer 2–3 times daily to intact skin of the intended area; not for nasal decongestion or oral use. ^{[1], [2]}

Specifications

Use racemic camphor RFE 0655, white beeswax RFE 0069 and BP White Soft Paraffin as specified. Finished ointment should be white, firm and homogeneous, without undissolved crystals. No numerical viscosity, assay or crystal-size acceptance limits are supplied. ^{[1], [2], [4]}

Light

Protect from light as specified. Packaging must provide this protection, although no particular container colour is required. Quantitative photostability data are not supplied. ^[1]

Air and oxidation

Camphor is volatile and sublimes even at room temperature. Limit open heating/mixing after addition, cool under control and promptly close the finished container to reduce active loss. ^{[1], [2], [3]}

Water and solubility

No water is added and equipment must be dry. The water bath is for indirect heating only; prevent droplets/condensate entering the ointment. No added water is not a measured aw result. ^{[1], [4], [5]}

Humidity

The general ointments procedure specifies relative humidity ≤60% and room temperature 25±5 °C. No specific humidity sensitivity of the ointment is provided; prioritise exclusion of bath water and closed raw-material containers. ^{[1], [4]}

Temperature

Melt the paraffin/wax base in a 50–70 °C water bath. Add camphor when the base permits complete dissolution with the least practical heat exposure. ICSC gives a flash point around 66 °C for neat camphor; this is not a measured ointment property but requires ignition control. Store below 30 °C. ^{[1], [2], [3]}

pH and compatibility

No pH is specified for this anhydrous fatty ointment. Aqueous extraction or buffer addition would introduce a different method/formula and is not added without evidence. ^{[1], [4]}

Other interactions

Keep camphor away from strong oxidisers, reducing agents and incompatible chlorinated solvents. Do not introduce ether or another organic solvent for trituration: this specific method dissolves camphor in the melted fatty base. ^{[1], [2], [3]}

Ingredient-specific information

Select racemic camphor meeting RFE 0655. ICSC notes CAS 21368-68-3 for the racemate; verify the actual supplier identity. White beeswax provides consistency and white soft paraffin is the vehicle; it is not liquid paraffin. ^{[1], [2], [3]}

Staff protection

Use gloves, coat, goggles and ventilation/extraction while weighing/adding camphor. Avoid dust/vapour inhalation. Use an electric water bath without flames, heat-resistant handling aids and a stable vessel; assess equipment suitability for a volatile combustible material. ^{[3], [4]}

Risk assessment

Not for children under 2; older children require medical direction and caution. Do not apply to wounds, mucosa, damaged skin or near nostrils. Camphor ingestion can cause seizures and respiratory depression. During lactation avoid sites where the infant could inhale vapour or contact/ingest the product. ^{[1], [2], [3]}

Compounding conditions

For 100 g, theoretical paraffin =100−10−8=82 g. Do not conceal camphor loss by blindly adding paraffin to 100 g, as this can mask low strength. Record actual masses, melting/addition temperatures and yield. ^{[1], [2], [4]}

BUD rationale

The source states three months in a plastic jar or tube, protected from light below 30 °C. Under documented local adoption of the exact formula/packaging, the ceiling is the earliest of 89 days, three calendar months and ingredient limits. No exact-formula study or measured aw was identified; a general 180-day limit is not assigned automatically. Camphor loss and recrystallisation are specific monitoring concerns. 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], [5]}

Prerequisites

Dependencies are the ointments procedure and specifications for the three raw materials. This 10/8/82 ratio is not interchangeable with the French 10/10/80 camphor ointment and does not use it as a ready base. ^{[1], [4]}

Equipment

Balance, dry heat-resistant vessel, electric 50–70 °C water bath, thermometer, semisolid-compatible spatula/stirrer and tightly closable jar or tube. Provide vapour control without unnecessary camphor loss from vigorous open mixing. ^{[1], [3], [4]}

Compounding method

1. Weigh camphor, white beeswax and calculated paraffin. 2. Melt paraffin and wax in a 50–70 °C water bath. 3. Add camphor and stir until dissolved, limiting heating time. 4. Continue stirring during cooling to obtain a homogeneous ointment. 5. Check mass/appearance and package with a tight closure. ^{[1], [2], [4]}

Observations

This is a genuine base variant relative to CGR-FR-023: 8% rather than 10% wax. A consistency difference does not establish equivalent drug release or clinical performance. Camphor odour is not a quantitative assay. ^{[1], [2], [4]}

Container and packaging

Use a plastic jar or tube as specified, with documented compatibility for camphor/fatty base and light protection. The source does not name a polymer; assess closure integrity, permeability and function before adoption. ^{[1], [2], [4]}

Quality control

Check mass balance, a white homogeneous firm ointment and absence of visible crystals/grit after cooling. For batches, the general procedure adds applicable spreadability and microbiological checks. No camphor assay or long-term recrystallisation test was performed here. ^{[1], [4]}

Storage

Store below 30 °C, protected from light and tightly closed. Avoid heating and repeated melting/solidification. Investigate separation or visible crystals before dispensing, without improvised reheating. ^{[1], [2], [4]}

Dispensing

Apply a thin layer to intact skin as directed. Confirm age, site and pregnancy/lactation status; avoid the nose and areas accessible to an infant. Explain ingestion risk and the need for immediate medical advice after child exposure. ^{[1], [2], [3]}

Labelling

Racemic camphor 10% w/w ointment with white beeswax 8% w/w. Cutaneous use only — do not swallow. Not for children under 2, wounds, mucosa or near the nose. Use as prescribed. Store below 30 °C, protected from light, tightly closed. Enter actual dates, batch and quantity during execution. ^{[1], [3]}

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 — POMADA ALCANFORADA (FN/2003/PO/021)FN/2003 source identifier; current standalone official PDF accessed 2026-10-13PDF pp. 2–3; composition, specific method, storage, validity and patient leafletMaster composition, preparation and source-specific conditions. Independently written factual adaptation; not an official translation or endorsement. No laboratory testing performed for this document.2026-10-14
AEMPS — Alcanfor racémico (FN/2003/PA/002)FN/2003; standalone official PDF accessed 2026-10-13PDF p. 2Raw-material identity, physical properties, incompatibilities and route-specific precautions; raw-material assay limits are not finished-product specifications.2026-10-13
ILO/WHO International Chemical Safety Card 1021 — CamphorJuly 2003Identity; hazards/prevention; physical properties; chemical dangers; notesOccupational hazards of the identified raw material. Neat-material flash points and toxicity are not measured finished-mixture properties.2026-10-13
AEMPS — Elaboración de pomadas (PN/L/FF/006/00)Official FN procedure, version 00, accessed 2026-10-13Sections 5–6: environment, preparation, packaging, finished-product checksOfficial general dosage-form procedure; exact formula method takes precedence; batch-level tests are distinct from tests actually performed.2026-10-13
USP — Compounding Standards and Beyond-Use DatesNovember 2022 update, official USP fact sheet hosted by Mississippi Board of PharmacyNonsterile preparation BUD overview and category tableGeneral BUD framework; an AEMPS source period is not automatically a USP–NF monograph exception, and no measured water activity is implied.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