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Vanishing cream — FNFB

CGR-BR-008 · ANVISA — Formulário Nacional da Farmacopeia Brasileira, 2ª edição, Revisão 02 (2012)

Historical source editionCGR-BR-008Brazil

HISTORICAL SOURCE EDITION — compare with the current edition before use.

Monograph PDF · GR/ENBlank batch worksheet
Dosage formSemi-solid base
Reference batch100 g
Monograph version4.0
Source packagev4

Source formula

IngredientSource quantity
Triethanolamine or aminomethylpropanol 95% (A)0.7 g
Sorbitol 70% w/w solution (A)3.7 g
FNFB paraben concentrate (A)3.3 g
Triple-pressed stearic acid (B)18 g
Liquid petrolatum (B)2 g
Lanolin (B)0.5 g
Sorbitan oleate (B)0.5 g
Purified water (A)q.s. ad 100 g

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

Description

Partial evidence

Semi-solid base: Vanishing cream — FNFB. Additional appearance criteria are not established by the specific text reviewed.

References: [1]

Use and action

Documented in source

O/W base containing partly saponified stearic acid.

References: [1]

Specifications

Not established

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

References: [1]

Light

Partial evidence

For the finished product the source specifies:
Well-closed opaque plastic container, protected from light, room temperature.

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

Not established

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

References: [1]

Humidity

Not established

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

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

Not established

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

References: [1]

Other incompatibilities

Partial evidence

Ethanol is incompatible with strong oxidants.

References: [2]

Ingredient-specific information

Partial evidence

Triethanolamine or aminomethylpropanol 95% (A): Ethanol: flammable vapour; control ignition sources and provide suitable ventilation. Final classification depends on concentration/mixture.
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]

Personal protective equipment

Partial evidence

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] · [3]

Risks and precautions

Partial evidence

Ethanol: flammable vapour; control ignition sources and provide suitable ventilation. Final classification depends on concentration/mixture.

References: [2]

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

Not established

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

Documented in source

Paraben concentrate 6% + 3% w/w → CGR-BR-001

References: [1]

Equipment

Editorial checklist

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

References: [1]

Preparation procedure

Documented in source

Heat B to 70 °C and A to 75 °C. Add A to B, stir vigorously for 10 minutes, then gently to room temperature.

References: [1]

Observations

Documented in source

Select one alkaline ingredient. Triethanolamine here is raw material, not the 50% auxiliary stock in this collection. Contains lanolin.

References: [1]

Packaging

Documented in source

Well-closed opaque plastic container, protected from light, room temperature.

References: [1]

Quality control

Not established

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

References: [1]

Storage

Documented in source

Well-closed opaque plastic container, protected from light, room temperature.

References: [1]

Dispensing and directions

Partial evidence

No additional special directions are established beyond the source route, storage and notes. Complete patient details, dose and directions from the prescription.

References: [1]

Labelling

editorial_specimen

Vanishing cream — FNFB
Strength/variant: __________ Quantity: __________
Batch: __________ Prepared: __________ Use by: __________
Για εργαστηριακή ενσωμάτωση / For incorporation during compounding
Dose/directions: __________
Storage: Well-closed opaque plastic container, protected from light, room temperature.

References: [1]

Sources and traceability

  1. ANVISA — Formulário Nacional da Farmacopeia Brasileira, 2ª edição, Revisão 02 (2012)

    2012, 2nd ed., Rev. 02 — superseded · PDF pp. 174 · A2

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

  2. niosh_ethanol

    Διαθέσιμο κείμενο / Retrieved text · Official reference · A1

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

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

    Διαθέσιμο κείμενο / Retrieved text · PDF pp. 1–5 · 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: fae6042725a0f699b5265a8afd31c137b1c821ef8ad514bcbf849689662978e6

Monograph PDF · GR/ENBlank batch worksheet