Stasinos Chr. Sikalias · The science of compounding

Mentholated zinc oxide powder PO020

CGR-ES-068 · FN/2003/PO/020 POLVOS DE ÓXIDO DE ZINC MENTOLADOS

For local reviewCGR-ES-068Spain · AEMPS

WORKSHEET FOR LOCAL APPROVAL — source authority does not replace batch approval.

The source batch total is 90 g. The 8 g menthol represents 8.89% w/w, not 8%.

The source batch total is 90 g. The 8 g menthol represents 8.89% w/w, not 8%.

Dosage formCutaneous powder
Reference batch90 g
Monograph version4.0
Source packagev4

Source formula

IngredientSource quantity
Racemic menthol8 g
Zinc oxide10 g
Talc37 g
Maize starch35 g

Quantities refer to the source batch. This website does not automatically scale formulas, assign doses or calculate BUD.

Description

Documented in source

White powder with menthol odour.

References: [1]

Use and action

Documented in source

Symptomatic relief of itching/mild irritation; plantar hyperhidrosis according to the source.

References: [1]

Specifications

Documented in source

White powder with menthol odour.

References: [1]

Light

Not established

No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

References: [1]

Air

Not established

No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

References: [1]

Water and solubility

Partial evidence

ZnO: practically insoluble in water and ethanol.

References: [2]

Humidity

Partial evidence

For the finished product the source specifies:
Powder sprinkler container; protect from moisture.

References: [1]

Temperature

Not established

No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

References: [1]

pH and related incompatibilities

Partial evidence

ZnO dissolves in dilute mineral acids and forms soaps with fatty acids.

References: [2]

Other incompatibilities

Partial evidence

Menthol forms eutectic mixtures with camphor/thymol; incompatible with strong oxidants.

References: [3]

Ingredient-specific information

Partial evidence

Zinc oxide: ZnO: practically insoluble in water and ethanol.
Racemic menthol: Menthol forms eutectic mixtures with camphor/thymol; incompatible with strong oxidants.
These are selected facts for identified ingredients; relevant sensitivities and incompatibilities are detailed in the corresponding fields. This is not a complete SDS for every material.

References: [2] · [3]

Personal protective equipment

Partial evidence

Menthol: eye protection and prevention of contact/dust inhalation.
Supplementary AEMPS framework: clean long-sleeved laboratory clothing, hair covering and dedicated footwear/overshoes. Powder handling requires suitable eye/respiratory protection; change gloves with activity or damage. Select the exact type/material using SDS and risk assessment.

References: [3] · [4]

Risks and precautions

Partial evidence

A complete formula-specific hazard classification is not established. Assess potency, dust/aerosol, allergens, solvents, microbial risk and cross-contamination using the actual materials and process. Absence of a flag does not establish absence of hazard.

References: [1]

Compounding conditions

Partial evidence

Follow the addition sequence, temperatures and times stated under Preparation Procedure. The specific monograph is not a complete qualification of the local facility/equipment.

References: [1]

BUD rationale

Documented in source

3 months under the source conditions.
The source period applies to its exact composition, method and packaging. It is not this batch’s expiry date and cannot be transferred to another vehicle/strength. Calculate the actual date in the blank batch record.

References: [1]

Bases and dependencies

Partial evidence

No separate base is identified in the dependency register. Check any commercial vehicles/compound excipients listed in the formula.

References: [1]

Equipment

Editorial checklist

Indicative checklist derived from the method: Balance of suitable resolution, Containers and mixing tools compatible with the materials, Mortar and pestle. Selection/qualification is defined locally.

References: [1]

Preparation procedure

Documented in source

Weigh, triturate and mix powders uniformly in the table order. Apply PN/L/OF/002/00.

References: [1] · [5]

Observations

Not established

No specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.

References: [1]

Packaging

Documented in source

Powder sprinkler container; protect from moisture.

References: [1]

Quality control

Partial evidence

White powder with menthol odour.

References: [1]

Storage

Documented in source

Powder sprinkler container; protect from moisture.

References: [1]

Dispensing and directions

Documented in source

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

References: [1]

Labelling

editorial_specimen

Mentholated zinc oxide powder PO020
Strength/variant: __________ Quantity: __________
Batch: __________ Prepared: __________ Use by: __________
Εξωτερική χρήση / External use
Dose/directions: __________
Storage: Powder sprinkler container; protect from moisture.
Not under 2 years. Do not inhale. Avoid eyes, nose, mucosa and open wounds. Not for infected or inflammatory/exudative dermatoses.

References: [1]

Sources and traceability

  1. FN/2003/PO/020 POLVOS DE ÓXIDO DE ZINC MENTOLADOS

    FN/2003 • ηλεκτρονικό κείμενο με NIPO 2020/2022 / electronic text with NIPO 2020/2022 · PDF pp. 2–3 · A1

    Review date reported in supplied metadata: 2026-09-10

  2. FN/2003/PA/028 ÓXIDO DE ZINC

    Διαθέσιμο κείμενο / Retrieved text · PDF pp. 1–2 · A1

    Review date reported in supplied metadata: 2026-09-10

  3. FN/2003/PA/021 MENTOL RACÉMICO

    Διαθέσιμο κείμενο / Retrieved text · PDF pp. 1–2 · A1

    Review date reported in supplied metadata: 2026-09-10

  4. PN/L/PG/002/00 INDUMENTARIA

    Διαθέσιμο κείμενο / Retrieved text · PDF pp. 1–5 · A1

    Review date reported in supplied metadata: 2026-09-10

  5. PN/L/OF/002/00 MEZCLADO DE POLVOS

    Διαθέσιμο κείμενο / Retrieved text · PDF pp. 1–6 · A1

    Review date reported in supplied metadata: 2026-09-10

Provenance and reuse

This record comes from the supplied v4 collection. Primary-source rights and licences remain separate. No new comprehensive licence review has been performed for the earlier 239 records.

SHA-256 of the supplied PDF: 53fede7616107cfe5c91e88abeb294612394def356b3ca8c07a42853ff14cbf5