Menthol petrolatum 1% PO031

Glossy white greasy ointment with menthol odour.

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Antipruritic and skin protectant according to the source.

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Glossy white greasy ointment with menthol odour.

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For the finished product the source specifies:
Opaque jar or metal tube, protect from light/moisture, <25°C.

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

References: [1]

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

References: [1]

For the finished product the source specifies:
Opaque jar or metal tube, protect from light/moisture, <25°C.

References: [1]

For the finished product the source specifies:
Opaque jar or metal tube, protect from light/moisture, <25°C.

References: [1]

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

References: [1]

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

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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]

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: [2] · [3]

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.

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The corresponding AEMPS SOP specifies room temperature 25 ± 5°C and relative humidity ≤60%, unless the particular formula requires otherwise. This is the work environment, not processing or storage temperature.
Follow the addition sequence, temperatures and times stated under Preparation Procedure. The specific monograph is not a complete qualification of the local facility/equipment.

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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.

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

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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.

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Triturate menthol and incorporate into petrolatum with a pestle until fully uniform.

References: [1] · [4]

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

References: [1]

Opaque jar or metal tube, protect from light/moisture, <25°C.

References: [1]

Glossy white greasy ointment with menthol odour.

References: [1]

Opaque jar or metal tube, protect from light/moisture, <25°C.

References: [1]

Not under 2 years, in/near the nose, on open wounds/mucosa or acute/subacute inflammatory dermatoses.

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Menthol petrolatum 1% PO031
Strength/variant: __________ Quantity: __________
Batch: __________ Prepared: __________ Use by: __________
Εξωτερική χρήση / External use
Dose/directions: __________
Storage: Opaque jar or metal tube, protect from light/moisture, <25°C.
Not under 2 years, in/near the nose, on open wounds/mucosa or acute/subacute inflammatory dermatoses.

References: [1]