Mentholated zinc oxide powder PO020

White powder with menthol odour. ^[1]

Symptomatic relief of itching/mild irritation; plantar hyperhidrosis according to the source. ^[1]

White powder with menthol odour. ^[1]

Finished-product photostability is not specified. Any required container light protection is stated under Storage. ^[1]

No oxidative stability study of the finished mixture or inert-atmosphere requirement is provided. Use the source container. ^[1]

ZnO: practically insoluble in water and ethanol.
Menthol: practically insoluble in water, readily soluble in fixed oils and liquid paraffin, very slightly soluble in glycerol.
Talc: JP classifies the corresponding pure raw material as practically insoluble in water. ^{[2], [3], [6]}

For the finished product the source specifies:
Powder sprinkler container; protect from moisture. ^[1]

Racemic menthol melts at approximately 34 °C; this is a raw-material processing characteristic. ^[3]

ZnO dissolves in dilute mineral acids and forms soaps with fatty acids. ^[2]

Menthol forms eutectic mixtures with camphor/thymol; incompatible with strong oxidants. ^[3]

Zinc oxide: light, white to slightly yellowish, amorphous powder without aggregates. Dilute mineral acids dissolve it; fatty acids in a base can form zinc salts.
Talc: raw-material water solubility is classified as practically insoluble by JP. ^{[2], [6]}

Menthol: eye protection and prevention of contact/dust inhalation.
Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage.
Contain powder during weighing and trituration and use eye protection; select respiratory protection for the actual exposure. ^{[3], [4], [7]}

Menthol: prevent contact with nasal mucosa in small children; laryngeal spasm and collapse have been reported below age 2. Avoid open wounds and mucosa.
Reference batch: 90 g. First ingredient: Racemic menthol, 8 g. Independently check chemical form, units and every scale conversion before weighing.
Weighing, sieving and trituration can disperse inhalable powder. Contain at source, check contamination of nearby preparations and avoid blowing or dry sweeping during cleaning.
For the local assessment record quantity per preparation, work frequency, duration of open handling, potential exposure routes and effectiveness of controls. These are assessment inputs; no fictitious final risk score is assigned.
Release checkpoint: independently verify mg per unit, total unit count and smallest weighable quantity. Mass uniformity does not replace content uniformity when required. Document geometric dilution and prevention of powder segregation. ^{[1], [3], [10], [12]}

Before mixing: verify each ingredient’s chemical form and lot, record theoretical amounts and check equipment cleanliness. Follow the temperatures and addition sequence in the procedure below. ^{[1], [7]}

Period reported by source: 3 months under the source conditions.
This duration is a specific formulary/source instruction. This review did not verify a complete primary study establishing chemical, physical and microbiological extension for the same finished formulation.
Selected general rule: up to 180 days at 20–25 °C for a solid or nonaqueous nonoral-liquid form with supported aw <0.6. Initial quality/moisture, exclusion of water ingress and physical suitability must support this category.
The reference-policy ceiling in this edition is the shorter of the source period above and the general ceiling. Extension needs matching active/excipients/strength, container, temperature, a stability-indicating method and the required microbiological evidence for aqueous extension. An applicable official USP–NF compounded monograph is assessed separately in its complete text.
Use-by date = the earliest allowed date from preparation plus selected period, ingredient expiries and any shorter supported limit. In-use dating never extends overall BUD. Complete the actual date for the batch after the required checks.
A default is a conservative dating limit, not experimental proof of batch stability. Its category depends on final composition, preservation and permitted temperatures. Water percentage or loss on drying does not determine aw. Document using SOP-014/F-006; use SOP-017/F-012 for specific aw evidence.
USP does not require water-activity measurement for every nonsterile preparation. A justified classification of the actual formulation may guide dating; record it explicitly as inferred, not measured. Uncertain or borderline classification requires specific evidence or a suitable measurement. Finished-product dating does not outlast the available dating of previously compounded components/bases unless adequate specific evidence for the exact finished preparation has been formally adopted.
Register correction: at most 89 days as a conservative reference cap before any shorter expiry/component date. This edition converts one calendar month to 28 days and three calendar months to 89 days; weeks are converted to seven days. Original source units are retained. This is an editorial conversion policy, not a new stability result or automatic release. ^{[1], [8], [9], [11], [13]}

No separately registered base is required. Any commercial vehicle remains the exact named product in the formula table. ^[1]

Balance, mortar/pestle, suitable sieve, mixing vessel and powder containment. ^[1]

Weigh, triturate and mix powders uniformly in the table order. Apply PN/L/OF/002/00. ^{[1], [5]}

The final quantity is the master-formula basis. Record actual yield, losses and deviations in the batch record. ^[1]

Powder sprinkler container; protect from moisture. ^[1]

White powder with menthol odour.
Record the method, acceptance criterion, actual result and reviewer separately in F-005. A critical specification failure requires quarantine and investigation under SOP-015; retesting needs justification. ^{[1], [12]}

Powder sprinkler container; protect from moisture. ^[1]

Not under 2 years. Do not inhale. Avoid eyes, nose, mucosa and open wounds. Not for infected or inflammatory/exudative dermatoses. ^[1]

Mentholated zinc oxide powder PO020
External use
Quantity: ____ Batch: ____
Prepared: ____ Use by: ____
Patient / dose / frequency: ____
Storage: Powder sprinkler container; protect from moisture.
Temperature for this batch BUD: ____ ^[1]

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.