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Acrinol Hydrate 1% and Zinc Oxide Ointment JP

Cutaneous ointment · Japan

CGR-JP-014 · Collection 8.0 · 12.09.2026Local adoption & batch approval
Local adoption & batch approval

Reference documentation. The actual use requires review, local adoption and batch approval.

MASTER FORMULA / v8.0

The source formula

Reference basis: 1000 g

IngredientSource quantityScaled quantity
Acrinol hydrate JP, very finely powdered10g—
Zinc Oxide Ointment JP — CGR-JP-006990g—

q.s.: sufficient quantity · ad: to a final total. Ingredient identities and source quantities are retained exactly from v8. [1]

FORMULA SCALING / 9.0

Calculate proportional quantities.

Arithmetic scaling of the same formula. It does not change strength, dose, method or BUD.

Formula scaling

Prerequisite formulations

Full documentation

Preparation descriptionDocumented in source
Yellow ointment. [1]
Action and usePartial evidence
Cutaneous acrinol and zinc oxide preparation. ZnO has protective/astringent skin action; JP gives no administration regimen for the combination. [1], [2]
SpecificationsDocumented in source
Acrinol hydrate 1% w/w. Using 990 g of 20% zinc oxide ointment gives nominal ZnO 198 g/1000 g = 19.8% w/w. This calculation is not an assay acceptance range. JP gives yellow appearance and identification tests but no numerical assay range for this ointment. [1]
Compounding methodEditorial procedure for local review
1. Verify and release the exact JP zinc oxide ointment CGR-JP-006. 2. Weigh 10 g very finely powdered acrinol hydrate and 990 g base. 3. Implement the general JP Ointments method by triturating acrinol with a small amount of base, then progressively incorporating the rest until homogeneous. 4. Limit light, check colour/distribution/final mass and package. This formula adds no water. [1]
Quality controlDocumented in source
Identify acrinol by the acidic nitrite reaction producing dark red colour in the aqueous layer; identify zinc in the ignited residue using JP <1.09>. Acrinol TLC at 365 nm shows blue fluorescence and the standard Rf. Analytical solvents and acids are used solely in testing according to JP pp. 416–417. Record the method, acceptance criterion, actual result and reviewer separately in F-005. A critical specification failure requires quarantine and investigation under SOP-015; retesting needs justification. [1], [14]
Container and packagingDocumented in source
Tight, light-resistant container as specified by JP. [1]
StoragePartial evidence
Protect from light; tight container. For a general-rule duration, also apply the temperature of the selected BUD category. The source does not support arbitrary temperature changes. [1], [6]
Risk assessmentEditorial checklist
Use the exact Acrinol Hydrate JP identity and CGR-JP-006 base. Another zinc oxide ointment changes composition and final strength. Reference batch: 1000 g. First ingredient: Acrinol hydrate JP, very finely powdered, 10 g. Independently check chemical form, units and every scale conversion before weighing. Check uniform active distribution and absence of aggregates after cooling. Overheating, water ingress or a changed base alter the preparation; record actual yield and transfer losses. For the local assessment record quantity per preparation, work frequency, duration of open handling, potential exposure routes and effectiveness of controls. These are assessment inputs; no fictitious final risk score is assigned. Release checkpoint: inspect aggregates, crystals, local texture differences and free liquid after completing the method. Record mixing geometry, batch size and actual temperatures; copying rpm to another mixer does not establish process equivalence. [1], [12], [14]
ObservationsPartial evidence
Use very finely powdered acrinol. An optional aqueous dissolution described for a different JP oil preparation does not apply to this ointment. [1]
LightNot specified in the reviewed source
Finished-product photostability is not specified. Any required container light protection is stated under Storage. [1]
Air and oxidationNot specified in the reviewed source
No oxidative stability study of the finished mixture or inert-atmosphere requirement is provided. Use the source container. [1]
Water and solubilityPartial evidence
ZnO: practically insoluble in water and ethanol. Component of base CGR-JP-006: Liquid Paraffin: JP classifies the corresponding pure raw material as practically insoluble in water. Component of base CGR-JP-005: White Petrolatum: JP classifies the corresponding pure raw material as practically insoluble in water. [2], [7], [8], [9], [10]
HumidityNot specified in the reviewed source
No numerical relative-humidity limit is given for the finished product. Prevent raw-material wetting and condensation entering the container. [1]
TemperatureNot specified in the reviewed source
No permitted temperature excursion or freeze–thaw cycle is established. Processing and storage temperatures are stated in their respective fields. [1]
pH and compatibilityPartial evidence
ZnO dissolves in dilute mineral acids and forms soaps with fatty acids. [2]
Other interactionsNot specified in the reviewed source
No complete compatibility test with added actives or alternative excipients is provided. Substitutions require separate evidence. [1]
Ingredient-specific informationPartial evidence
Zinc oxide: light, white to slightly yellowish, amorphous powder without aggregates. Dilute mineral acids dissolve it; fatty acids in a base can form zinc salts. Component of base CGR-JP-006: Liquid Paraffin: raw-material water solubility is classified as practically insoluble by JP. Component of base CGR-JP-005: White Petrolatum: raw-material water solubility is classified as practically insoluble by JP. [2], [7], [8], [9], [10]
Compounding conditionsEditorial checklist
Use identified raw materials and clean compatible equipment. Retain the addition sequence, material forms and temperatures in the Procedure. Record actual conditions and deviations for each batch. [1], [4]
Staff protectionPartial evidence
Clean long-sleeved laboratory clothing, hair covering and gloves during handling; change gloves after contamination or damage. Contain powder during weighing and trituration and use eye protection; select respiratory protection for the actual exposure. [3], [4]
BUD rationaleGeneral framework, subject to conditions
No specific experimental period was located covering the complete exact formulation, container and microbiological suitability. Selected general rule: up to 180 days at 20–25 °C for a solid or nonaqueous nonoral-liquid form with supported aw <0.6. Initial quality/moisture, exclusion of water ingress and physical suitability must support this category. Use-by date = the earliest allowed date from preparation plus selected period, ingredient expiries and any shorter supported limit. In-use dating never extends overall BUD. Complete the actual date for the batch after the required checks. A default is a conservative dating limit, not experimental proof of batch stability. Its category depends on final composition, preservation and permitted temperatures. Water percentage or loss on drying does not determine aw. Document using SOP-014/F-006; use SOP-017/F-012 for specific aw evidence. [1], [11], [13]
PrerequisitesDocumented in source
Zinc Oxide Ointment JP 20% w/w: CGR-JP-006 [1]
EquipmentEditorial checklist
Balance with suitable minimum weight, mortar/pestle or homogeniser, mixing vessels, spatulas, thermometer for heated processes and volumetric equipment for mL quantities. [1]
LabellingEditorial specimen
Acrinol Hydrate 1% and Zinc Oxide Ointment JP External use Quantity: ____ Batch: ____ Prepared: ____ Use by: ____ Patient / dose / frequency: ____ Storage: Protect from light; tight container. Temperature for this batch BUD: ____ [1]
DispensingPartial evidence
Emollient residues on clothing, dressings or bedding accelerate fabric ignition. Avoid smoking and naked flames during use. [5]

Independent Greek/English adaptation and organisation of facts from the cited source. This is not an official translation or publisher endorsement.

Sources and references

  1. MHLW — Japanese Pharmacopoeia XVIII: Acrinol Hydrate 1% and Zinc Oxide Ointment JPJP XVIII, 2021; English textPrinted pp. 416–417; Acrinol Hydrate pp. 414–415; General Rules: Ointmentsmaster formula, description, tests and container2026-09-12
  2. FN/2003/PA/028 ÓXIDO DE ZINCRetrieved source editionSections 4, 6–10ingredient facts2026-09-12
  3. PN/L/PG/002/00 INDUMENTARIARetrieved source editionFull cited procedureingredient facts2026-09-12
  4. ASHP — USP <795> Key Changes2023pp. 1–3: scope, water activity and staff precautionsprofessional guidance; not the licensed USP chapter2026-09-12
  5. MHRA — Emollients and risk of severe and fatal burns: new resources available26 August 2020; updated 20 May 2021Fabric contamination and fire riskclinical safety2026-09-12
  6. Texas State Board of Pharmacy — adopted 22 TAC §291.131, nonsterile compoundingTexas Register, 7 June 2024Beyond-use dating: aw categories, 14/35/90/180 days, limits and extensionspublic regulatory implementation of USP <795> BUD framework; not Greek law2026-09-12
  7. MHLW — Japanese Pharmacopoeia XVIII: Liquid ParaffinJP XVIII, 2021; English textPrinted p. 1477; Description; Containers and storageraw-material monograph2026-09-12
  8. MHLW — JP XVIII: Zinc Oxide Ointment JP 20% w/w2021JP XVIII (2021), printed pp. 1929–1930; General Rules 11-4, p. 20specific formulation2026-09-10
  9. MHLW — Japanese Pharmacopoeia XVIII: White PetrolatumJP XVIII, 2021; English textPrinted p. 1501; Description; Containers and storageraw-material monograph2026-09-12
  10. MHLW — JP XVIII: White Ointment JP2021JP XVIII (2021), printed p. 1921; General Rules for Preparations 11-4, p. 20specific formulation2026-09-10
  11. Illinois IDFPR — Nonsterile Compounding Self-Inspection ReportPublic checklist, retrieved 12 September 2026pp. 15–16, Establishing beyond-use datesPublic regulatory implementation of USP <795>; not Greek law; general limits and requirements for extension2026-09-12
  12. NIOSH — Managing Hazardous Drug Exposures: Information for Healthcare Settings2023; DHHS (NIOSH) 2023-130Risk assessment; printed pp. 27–33, activity/formulation control tableWorkplace exposure, hierarchy of controls and activity-specific PPE; US government public-domain document2026-09-12
  13. USP — Compounding Standards and Beyond-Use Dates, 2022 updateNovember 2022, published by USP; public copy hosted by Mississippi Boardpp. 1–2; nonsterile tableRisk-based default categories; not product-specific stability or Greek law2026-09-12
  14. PIC/S — Guide to Good Practices for the Preparation of Medicinal Products in Healthcare EstablishmentsPE 010-4, 1 March 2014Chapters 1–9; Annex 2 (nonsterile liquids, creams, ointments)Professional quality-system framework; not automatic national legal adoption or certification2026-09-12
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