White Ointment JP
CGR-JP-005 · MHLW — JP XVIII: White Ointment JP
Documented bibliographic addition; requires local scientific approval before use as a master formulation record.
Source formula
| Ingredient | Source quantity |
|---|---|
| White beeswax | 50 g |
| Sorbitan sesquioleate | 20 g |
| White petrolatum | q.s. ad 1000 g |
Quantities refer to the source batch. This website does not automatically scale formulas, assign doses or calculate BUD.
Description
Documented in sourceWhite ointment with a slight characteristic odour.
References: [1]
Use and action
Partial evidenceLipophilic ointment base. JP specifies it as the base of Zinc Oxide Ointment. This monograph does not provide an independent therapeutic indication or dose.
References: [1]
Specifications
Documented in sourceWhite appearance, slight characteristic odour and viscosity suitable for cutaneous application under JP 11-4. No numerical viscosity limit, pH or product-specific assay is given.
References: [1]
Light
Not establishedNo specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.
References: [1]
Air
Not establishedNo specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.
References: [1]
Water and solubility
Not establishedNo specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.
References: [1]
Humidity
Not establishedNo specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.
References: [1]
Temperature
Not establishedNo specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.
References: [1]
pH and related incompatibilities
Not establishedNo specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.
References: [1]
Other incompatibilities
Not establishedNo specific finished-product information is established in the reviewed sources. Additional evidence is required before defining a specification.
References: [1]
Ingredient-specific information
Partial evidenceExact identities: Λευκός κηρός μελισσών / White beeswax; Σεσκιελαϊκός εστέρας σορβιτάνης / Sorbitan sesquioleate; Λευκή βαζελίνη / White petrolatum. Use pharmacopoeial raw materials of the referenced edition, with CoA verification. Do not arbitrarily change salt, hydration state or strength. Record the actual q.s. amount in the batch.
References: [1]
Compounding conditions
Editorial checklistJP provides no specific numerical room limits for this formula. Define a local SOP covering suitable clean conditions, temperature control and contamination prevention. This is an editorial checklist.
Personal protective equipment
Partial evidenceClean protective clothing and head covering under AEMPS PN/L/PG/002/00. Use suitable gloves where contact is possible and respiratory/eye protection where powder handling requires it. Exact glove material, ventilation and respiratory protection must follow the SDS and local exposure assessment.
References: [4]
Risks and precautions
Partial evidenceBase without a medicinal active. Local assessment includes hot melt, burns, ingredient allergy and contamination risk. No potent-drug classification has been established.
References: [1]
BUD rationale
Not establishedThe specific monograph provides no finished-product beyond-use period/BUD. No duration is assigned by assumption. Suitable stability evidence and responsible-pharmacist approval are required before release.
References: [1]
Bases and dependencies
Documented in sourceNo separate compound base is required in the explicit formula.
References: [1]
Equipment
Editorial checklistBalance with suitable resolution, mortar/spatula, suitable mixing vessels and final container. Add volumetric equipment for mL, a controlled water bath where melting is specified and a suitable filter where required. Analytical equipment follows the QC methods.
Preparation procedure
Partial evidence1. Weigh the ingredients; theoretical white petrolatum is 930 g.
2. Melt and mix the lipophilic base components by controlled warming under JP 11-4.
3. Mix/knead until homogeneous. The local SOP must define the exact temperature, time and mixing speed; the monograph does not provide them.
Observations
Partial evidenceOriginal bilingual rendering of the formula and specifications. This base differs from Simple Ointment BP, USP White Ointment and plain petrolatum.
References: [1]
Packaging
Partial evidenceTight container. No specific container material is prescribed.
References: [1]
Labelling
editorial_specimenWhite Ointment JP
Quantity: _____ · Batch: _____ · Prepared: _____ · Use by: _____
External use only. Storage: Keep tightly closed. No specific temperature or light protection is prescribed for the finished product.
Patient/directions or laboratory use: _____ · Pharmacy/telephone: _____
Specimen for pharmacist adaptation; not a final approved label.
References: [1]
Quality control
Partial evidenceCheck appearance, odour and suitable consistency under the monograph/JP 11-4. Final mass and homogeneity are proposed local process checks. They do not replace overall JP conformity or establish a beyond-use period.
Storage
Partial evidenceKeep tightly closed. No specific temperature or light protection is prescribed for the finished product.
References: [1]
Dispensing and directions
Partial evidenceIntended for pharmaceutical use as a base. Adding an active requires compatibility assessment and separate evidence for the finished preparation.
References: [1]
Sources and traceability
- MHLW — JP XVIII: White Ointment JP
2021 · JP XVIII (2021), printed p. 1921; General Rules for Preparations 11-4, p. 20 · A1 official pharmacopoeia
Review date reported in supplied metadata: 2026-09-10
- MHLW — JP XVIII, General Rules for Preparations
2021 · 11-4 Ointments and 11-2 Cutaneous liquids, printed p. 20; Other Preparations 3 Spirits, p. 22; General Notices · A1 official pharmacopoeia
Review date reported in supplied metadata: 2026-09-10
- PN/L/FF/006/00 ELABORACIÓN DE POMADAS
PN/L/FF/006/00 · §4.3 environment; §4.4 method; §4.6 controls · A2 official technical guidance
Review date reported in supplied metadata: 2026-09-10
- PN/L/PG/002/00 INDUMENTARIA
PN/L/PG/002/00 · Clothing and protective equipment · A2 official technical guidance
Review date reported in supplied metadata: 2026-09-10
- AEMPS — Aviso legal
Policy checked 2026-09-10 · Reuse conditions · Rights policy, not clinical evidence
Review date reported in supplied metadata: 2026-09-10
- BOE — Real Decreto 1495/2011, artículos 7–10 y anexo
Policy checked 2026-09-10 · Reuse conditions · Rights policy, not clinical evidence
Review date reported in supplied metadata: 2026-09-10
- MHLW — Copyright and Public Data License policy
Policy checked 2026-09-10 · Reuse conditions · Rights policy, not clinical evidence
Review date reported in supplied metadata: 2026-09-10
- Digital Agency — Public Data License 1.0
Policy checked 2026-09-10 · Reuse conditions · Rights policy, not clinical evidence
Review date reported in supplied metadata: 2026-09-10
- PMDA — JP XVIII supplements and errata index
Supplement I 2022; II 2024; base errata March 2026 · Selected entries checked; no change to these four compositions identified · A1 official edition control
Review date reported in supplied metadata: 2026-09-10
Provenance and reuse
Source: Ministry of Health, Labour and Welfare, Japan, Japanese Pharmacopoeia XVIII, English edition 2021. Reuse under Public Data License 1.0 through the MHLW policy, with source attribution and changes identified. Greek translation, English summary/restructuring and editorial additions: Greek Formulary Sikalias, Stasinos Chr. Sikalias, compounding.gr. This is not an official translation or MHLW endorsement. The Japanese original prevails if it differs from the official English rendering. No logos or specially restricted third-party material are used. Supplementary AEMPS/CDC information is attributed separately.
SHA-256 of the supplied PDF: 41fde177485bcc37f07dcb8e9f3b8be948ab3f3aec749389dc3e775532a5fb66