Calamine lotion PO014

Whitish fine glossy suspension with characteristic odour.

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Relief of itching/skin irritation.

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Whitish fine glossy suspension with characteristic odour.

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For the finished product the source specifies:
Airtight plastic bottle, protect from light, <30°C.

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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.
Calamine is practically insoluble in water/ethanol.
ZnO: practically insoluble in water and ethanol.

References: [2] · [3] · [4]

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

References: [2]

For the finished product the source specifies:
Airtight plastic bottle, protect from light, <30°C.

References: [1]

Calamine reacts with acids, releasing gas.
ZnO dissolves in dilute mineral acids and forms soaps with fatty acids.

References: [3] · [4]

Glycerol: hazardous reaction with strong oxidising agents.

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Glycerol: Glycerol is hygroscopic; limit raw-material exposure to moisture.
Calamine: Calamine is practically insoluble in water/ethanol.
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.

References: [2] · [3] · [4]

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.

References: [1] · [6]

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.

References: [1] · [7]

2 weeks according to the source.
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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AEMPS EX023 Bentonite magma → CGR-ES-057

• CGR-ES-057 · Bentonite magma 5% EX023

References: [1] · [5]

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

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Prepare EX023. Dilute 25 mL magma with 25 mL water. Mix calamine, ZnO, glycerol and about 25 g of this diluted magma to a homogeneous paste. Incorporate into the remaining diluted magma and add remaining water to final volume.

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The 25 g is an aliquot of already diluted magma, not a replacement for the 25 mL original EX023. The main text cites the solution SOP, while environment/form refer to suspensions.

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Airtight plastic bottle, protect from light, <30°C.

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Whitish fine glossy suspension with characteristic odour.
Additional tests from the referenced SOP:
Appearance and mass/volume. For batches: sedimentation rate, viscosity RFE 2.2.8, relative density 2.2.5, pH and microbiological testing RFE 5.1.4.
pH under PN/CP/001: normally test the untreated sample unless otherwise specified. Accurate measurement follows potentiometric RFE 2.2.3; strips are limited to checks not requiring high accuracy.

References: [1] · [7] · [8]

Airtight plastic bottle, protect from light, <30°C.

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Shake. Not under 2 years, on eyes/mucosa/open wounds or infected dermatoses. Do not use beyond 7 days without medical advice.

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Calamine lotion PO014
Strength/variant: __________ Quantity: __________
Batch: __________ Prepared: __________ Use by: __________
Εξωτερική χρήση / External use
Dose/directions: __________
Storage: Airtight plastic bottle, protect from light, <30°C.
Shake before use.
Shake. Not under 2 years, on eyes/mucosa/open wounds or infected dermatoses. Do not use beyond 7 days without medical advice.

References: [1]