Sodium fluoride 0.05% w/v mouth rinse
CGR-BR-011 · ANVISA — Formulário Nacional da Farmacopeia Brasileira, 2ª edição, Revisão 02 (2012)
HISTORICAL SOURCE EDITION — compare with the current edition before use.
Source formula
| Ingredient | Source quantity |
|---|---|
| Sodium fluoride | 50 mg |
| FNFB paraben concentrate | 2 g |
| Flavour | q.s. |
| Purified water | q.s. ad 100 mL |
Quantities refer to the source batch. This website does not automatically scale formulas, assign doses or calculate BUD.
Description
Partial evidenceOromucosal preparation: Sodium fluoride 0.05% w/v mouth rinse. Additional appearance criteria are not established by the specific text reviewed.
References: [1]
Use and action
Documented in sourceDental-caries prevention by mouth rinsing.
References: [1]
Specifications
Not establishedNo specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.
References: [1]
Light
Partial evidenceFor the finished product the source specifies:
Tight 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
Not establishedNo specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.
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
Documented in sourceThe source reports slow decomposition/alkalinisation of NaF solutions in glass and incompatibility with Ca/Mg salts.
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
Documented in sourceParaben concentrate 6% + 3% w/w → CGR-BR-001
References: [1]
Equipment
Editorial checklistIndicative checklist derived from the method: Balance of suitable resolution, Containers and mixing tools compatible with the materials. Selection/qualification is defined locally.
References: [1]
Preparation procedure
Documented in sourceDissolve sodium fluoride in part of the water; add preservative, mix, add flavour and make to volume.
References: [1]
Observations
Documented in sourceMouth rinse; do not swallow. Source reports calcium/magnesium salt incompatibility and alkalinisation during glass storage.
References: [1]
Packaging
Documented in sourceTightly closed plastic bottle.
References: [1]
Quality control
Not establishedNo specific information is established by the consulted sources. Complete this before local approval where critical to this preparation.
References: [1]
Storage
Documented in sourceTight plastic container, protected from light, room temperature.
References: [1]
Dispensing and directions
Documented in sourceDo not swallow; exercise particular care with children. Avoid food/drink for about 30 min after rinsing as the source directs.
References: [1]
Labelling
editorial_specimenSodium fluoride 0.05% w/v mouth rinse
Strength/variant: __________ Quantity: __________
Batch: __________ Prepared: __________ Use by: __________
Στοματοβλεννογόνια χρήση / Oromucosal use
Dose/directions: __________
Storage: Tight plastic container, protected from light, room temperature.
Do not swallow; exercise particular care with children. Avoid food/drink for about 30 min after rinsing as the source directs.
References: [1]
Sources and traceability
- ANVISA — Formulário Nacional da Farmacopeia Brasileira, 2ª edição, Revisão 02 (2012)
2012, 2nd ed., Rev. 02 — superseded · PDF pp. 83 · 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: 91cfae7a6e79ca5fd665a95fd3f48af3733b9e44dac39f23f7beae9db8e0eb0c