Salicylic acid 6% and triamcinolone acetonide 0.1% gel · CGR-ES-080 (CGR-ES-080)

REFERENCE FORMULA

Reference formula

Reference basis: 100 g finished preparation; strengths w/w

Ingredient	Source quantity	Scaled quantity
Salicylic acid	6 g	—
Triamcinolone acetonide	0.1 g	—
Propylene glycol	60 g	—
Hydroxypropyl guar gum	2 g	—
Ethanol 96%	6 g	—
Purified water	q.s. ad 100 g	—

Prerequisite formulations

No separate prerequisite monograph is listed.

Documentation

Preparation description

Nearly transparent, colourless viscous gel. Each 1 g supplies 60 mg salicylic acid and 1 mg triamcinolone acetonide. ^[1]

Action and use

Keratolytic/corticosteroid combination for the localised psoriatic lesions/scalp dermatitis described by the source. Prescriber defines site, duration and frequency; finished-vehicle potency is not equated with a commercial cream. ^{[1], [2]}

Specifications

Verify raw-material identities/amounts, final mass 100 g and nearly clear colourless gel without visible crystals or heterogeneity. This monograph supplies no numeric API assay, viscosity, microbial or finished-pH limits. ^[1]

Light

Use opaque packaging and protect during storage; this storage instruction is not a quantitative photostability study. ^[1]

Air and oxidation

Limit open handling and entrained air: volatile solvent loss can change mass and solvent capacity. No inert-gas requirement is established. ^{[1], [3]}

Water and solubility

Water hydrates the polymer; it is not an optional diluent. Use purified water and make up by mass; do not replace propylene glycol with water. ^[1]

Humidity

Keep propylene glycol and dry polymer closed to maintain reproducible weighing/hydration. No numeric room-humidity limit is given for this gel. ^[1]

Temperature

Source specifies 50 °C water-bath steps for salicylic acid dissolution and the steroid alcoholic solution. Use equipment suitable for flammable vapours with ignition sources excluded. Store below 30 °C. ^{[1], [3]}

pH and compatibility

No final pH is specified. Source mentions lactic acid drops only if gel has not formed after 12 hours, without dose or target pH. Do not acidify empirically: quarantine failed gel for investigation and validation of any adjustment. ^[1]

Other interactions

Concurrent keratolytics/irritants increase local irritation. Segregate ethanol from strong oxidisers during processing. Compatibility with additional actives has not been established. ^{[1], [3]}

Ingredient-specific information

Use triamcinolone acetonide, not another triamcinolone form, and hydroxypropyl guar rather than carbomer or hydroxypropyl cellulose. Propylene glycol 60% is an essential cosolvent; its presence alone does not establish aw < 0.60. ^{[1], [4]}

Staff protection

Use coat, material-compatible gloves and eye protection. Contain powder when weighing 100 mg steroid; use local vapour extraction for warmed ethanol, exclude flames/sparks and prevent cross-contamination. ^{[1], [2], [3]}

Risk assessment

Critical points are steroid decimal error, ethanol loss and failed gelation. Large, inflamed or occluded areas increase systemic exposure; children are particularly susceptible to steroid effects including atrophy and HPA suppression. Source contraindicates use below 2 years. ^{[1], [2]}

Compounding conditions

Independently check 0.100 g steroid weighing. Scale fixed masses by k and make up to 100 k g with water. Without optional acid, theoretical water is 25.9 g; volatile losses must be controlled, not ignored. ^[1]

BUD rationale

AEMPS assigns 3 months below 30 °C and protected from light. Reference ceiling is 89 days and no later than 3 calendar months, conditional on exact formulation, suitable container and local quality-system adoption. No independent matched guar/vehicle stability study or aw/AET data were retrieved; this is not a validated USP limit. Earlier ingredient expiry or gel failure overrides it. 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

No premade base. Contingent lactic-acid adjustment is not automatically added to the formula; any use needs an approved local instruction and a recorded quantity. ^[1]

Equipment

Balance with suitable minimum weight for 100 mg, water bath/thermometer, vessels, gentle stirrer and tube-filling equipment. Optional pH trending supports local consistency, not an invented release limit. ^[1]

Compounding method

1. Disperse guar in the water and add 30 g propylene glycol. 2. Dissolve 6 g salicylic acid in the remaining 30 g propylene glycol at 50 °C and gently combine. 3. Dissolve 0.1 g steroid in 6 g ethanol 96% using the source 50 °C step with vapour control, then incorporate without aeration. 4. Check mass, uniformity and gelation. Failure to gel by 12 hours requires investigation before release. ^{[1], [3]}

Observations

Strengths are 60 mg/g and 1 mg/g, not mg/mL. Record actual amounts, temperatures and losses in the batch record. Uncontrolled extra water or acid produces a different formulation. ^[1]

Container and packaging

Opaque jar or compatible plastic tube as specified by the source, with effective closure. Document compatibility with the hydroalcoholic/glycol vehicle. ^[1]

Quality control

Verify calculations, final mass, dissolution/no visible crystals, uniformity, bubbles and container integrity. Use validated assay/microbial methods where required by the local plan; none were performed for this compilation. ^[1]

Storage

Keep closed, light-protected and below 30 °C. Freezing or alternating refrigerated storage is not established for this gel. ^[1]

Dispensing

Use only on the prescribed skin site for the specified course. Avoid eyes/mucosa, unprescribed occlusion and breast application during nursing. Seek review for infection, marked irritation or salicylate-toxicity symptoms. ^[1]

Labelling

Salicylic acid 6% + triamcinolone acetonide 0.1% · FOR SKIN USE. Quantity/directions:__. Store below 30 °C, protected from light and children. Batch__/Prepared__/Use by__. ^[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 — FN/2003/FMT/005 ÁCIDO SALICÍLICO Y TRIAMCINOLONA ACETÓNIDO, GEL DECurrent AEMPS standalone PDF; code FN/2003/FMT/005PDF p 2 §§3–7; subsequent safety and patient informationExact formulation, process, source shelf life and formulation-specific precautions; independent factual compilation, not official translation.2026-10-14
DailyMed — Triamcinolone acetonide cream USP 0.1%, NuCare labelRetrieved 13 October 2026Clinical pharmacology; precautions/general and paediatric useActive-class dermal absorption and steroid toxicity. Commercial cream is not the AEMPS gel; potency or BUD is not transferred.2026-10-13
CDC/NIOSH Pocket Guide — Ethyl alcoholPage reviewed 30 October 2019; retrieved 13 October 2026Flammability, incompatibilities and personal protectionEthanol raw-material handling; not a measured flash point or hazard classification of the finished mixture.2026-10-13
USP — Compounding Standards and Beyond-Use DatesNovember 2022 USP publication, public copy hosted by Mississippi Boardp 2 nonsterile comparison tableGeneral category limits only; not product-specific stability, antimicrobial effectiveness or Greek law.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