Aqueous zinc paste PO017

Viscous white paste.

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Cutaneous astringent/drying preparation.

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Viscous white paste.

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

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

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Glycerol is miscible with water. This does not establish product microbiological stability.
ZnO: practically insoluble in water and ethanol.

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Glycerol is hygroscopic; limit raw-material exposure to moisture.

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

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

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Glycerol: hazardous reaction with strong oxidising agents.

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Glycerol: Glycerol is hygroscopic; limit raw-material exposure to moisture.
Zinc oxide: ZnO: practically insoluble in water and ethanol.
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.

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Complete formula-specific PPE is not specified. Select gloves, eye protection and exposure controls using the exact materials’ SDS and the local risk assessment.
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.

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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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Mix water and glycerol. Finely triturate talc/ZnO and stir into the liquid until a smooth homogeneous paste forms.

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The table/sum is 100 g, but the leaflet says 110 g. The main formula is retained. The ZnO raw-material RFE reference incorrectly matches glycerol and needs clarification.

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Airtight plastic container. The source requires no special storage conditions.

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Viscous white paste.
Additional tests from the referenced SOP:
Appearance and mass. For batches: spreadability and microbiological testing RFE 5.1.4.
Spreadability PN/CP/003: fixed sample quantity between glass plates, with locally defined successive loads and times; measure two diameters and compare area against load. Temperature variation of ±0.5°C is suggested. The source gives no universal acceptance limit; establish it locally.

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Airtight plastic container. The source requires no special storage conditions.

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External use. Stir before use if a liquid layer separates. Granuloma risk in open wounds and possible allergic reactions.

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Aqueous zinc paste PO017
Strength/variant: __________ Quantity: __________
Batch: __________ Prepared: __________ Use by: __________
Εξωτερική χρήση / External use
Dose/directions: __________
Storage: Airtight plastic container. The source requires no special storage conditions.
External use. Stir before use if a liquid layer separates. Granuloma risk in open wounds and possible allergic reactions.

References: [1]