Anionic cream I — FNFB
CGR-BR-009 · ANVISA — Formulário Nacional da Farmacopeia Brasileira, 2ª edição, Revisão 02 (2012)
HISTORICAL SOURCE EDITION — compare with the current edition before use.
Web edition 4.0 correction: Correction of internal base cross-references. Use the following register IDs instead of the IDs in the original PDF Dependencies field:
Paraben concentrate 6% + 3% w/w → CGR-BR-001
Imidazolidinyl urea 50% w/v preservative solution → CGR-BR-003
Source formula
| Ingredient | Source quantity |
|---|---|
| Disodium edetate (A) | 0.1 g |
| FNFB paraben concentrate (A) | 3.3 g |
| DEA cetyl phosphate (A) | 1.5 g |
| Capric/caprylic triglycerides (B) | 4 g |
| Cetostearyl alcohol 30:70 (B) | 9 g |
| Butylated hydroxytoluene (B) | 0.05 g |
| Cyclomethicone (C) | 2 g |
| Imidazolidinyl urea 50% w/v solution (C) | 0.6 g |
| Purified water (A) | q.s. ad 100 g |
| FNFB pH adjuster, if required | q.s. pH 5.5–6.5 |
Quantities refer to the source batch. This website does not automatically scale formulas, assign doses or calculate BUD.
Description
Partial evidenceSemi-solid base: Anionic cream I — FNFB. Additional appearance criteria are not established by the specific text reviewed.
References: [1]
Use and action
Documented in sourceAnionic emollient O/W base.
References: [1]
Specifications
Documented in sourcepH 5.5–6.5.
References: [1]
Light
Partial evidenceFor the finished product the source specifies:
Well-closed opaque plastic container, protected from light, room temperature.
References: [1]
Air
Not establishedNo specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.
References: [1]
Water and solubility
Not establishedNo specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.
References: [1]
Humidity
Not establishedNo specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.
References: [1]
Temperature
Not establishedNo 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 evidenceSpecification of this preparation, not a demonstrated stability range:
pH 5.5–6.5.
References: [1]
Other incompatibilities
Not establishedNo specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.
References: [1]
Ingredient-specific information
Not establishedNo specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.
References: [1]
Personal protective equipment
Partial evidenceComplete 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.
Risks and precautions
Partial evidenceA 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 evidenceFollow 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 establishedNo 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
Editorial correctionParaben concentrate 6% + 3% w/w → CGR-BR-001
Imidazolidinyl urea 50% w/v preservative solution → CGR-BR-003
Equipment
Editorial checklistIndicative checklist derived from the method: Balance of suitable resolution, Containers and mixing tools compatible with the materials, Controlled heating and thermometer, Calibrated pH meter. Selection/qualification is defined locally.
References: [1]
Preparation procedure
Documented in sourceHeat A and B separately to 70–75 °C. Add A to B with gentle stirring. Add C at about 40 °C; check/adjust pH.
References: [1]
Observations
Documented in source30:70 specifies cetostearyl alcohol composition. Document the exact pH adjuster and grades in the local master record.
References: [1]
Packaging
Documented in sourceWell-closed opaque plastic container, protected from light, room temperature.
References: [1]
Quality control
Partial evidencepH 5.5–6.5.
References: [1]
Storage
Documented in sourceWell-closed opaque plastic container, protected from light, room temperature.
References: [1]
Dispensing and directions
Partial evidenceNo 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_specimenAnionic cream I — 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
- ANVISA — Formulário Nacional da Farmacopeia Brasileira, 2ª edição, Revisão 02 (2012)
2012, 2nd ed., Rev. 02 — superseded · PDF pp. 171 · A2
Review date reported in supplied metadata: 2026-09-10
- 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: 7b230bd4cdb231137686860cf1a4d16935585467e4a14eebd7135939f2eeb1e9