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Topicals & local formats · Contract manufacturing in India

Benzyl Alcohol 1.00% w/w, Diclofenac Sodium 1.00% w/w, Menthol 5% w/w, Mephenesin 5% w/w, Methyl Salicylate 5% w/w, Oleum Lini (Containing Predominantly Linolenic Acid) 3% w/w Topical ointment

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Discuss third-party manufacturing of Benzyl Alcohol 1.00% w/w, Diclofenac Sodium 1.00% w/w, Menthol 5% w/w, Mephenesin 5% w/w, Methyl Salicylate 5% w/w, Oleum Lini (Containing Predominantly Linolenic Acid) 3% w/w Topical ointment with Walter Healthcare, India. Share your target market, required pack count and fill weight, packaging and launch timeline for a product-specific quotation.

Catalogue reference
WH-5605
Composition and strength
Benzyl Alcohol 1.00% w/w, Diclofenac Sodium 1.00% w/w, Menthol 5% w/w, Mephenesin 5% w/w, Methyl Salicylate 5% w/w, Oleum Lini (Containing Predominantly Linolenic Acid) 3% w/w
Dosage form
Topical ointment
Indicative administration route
Topical
Therapeutic navigation area
Dermatology & topical care
Pharmacological class
Counterirritant / topical analgesic + NSAID analgesic + Skeletal muscle relaxant
Manufacturing stream
Non-beta-lactam

Catalogue details support an initial B2B discussion. Walter confirms the applicable unit, current licence scope, formula, target market and commercial feasibility before making a commitment.

Clinical reference

Mechanism and pharmacokinetics.

Explore the published evidence for the ingredients in Benzyl Alcohol 1.00% w/w, Diclofenac Sodium 1.00% w/w, Menthol 5% w/w, Mephenesin 5% w/w, Methyl Salicylate 5% w/w, Oleum Lini (Containing Predominantly Linolenic Acid) 3% w/w Topical ointment. Each reference identifies its source formulation and study context. Ingredient studies describe the named reference product; they do not establish the pharmacokinetics, clinical suitability or bioequivalence of this finished formulation.

How to read our product information and sources ↗

Additional ingredient references still to be verified: Benzyl Alcohol; Menthol; Mephenesin; Methyl Salicylate; Oleum Lini (Containing Predominantly Linolenic Acid). The references below cover only the named ingredients.

Prescribing-label excerpts

Diclofenac Sodium

Reference for: Diclofenac Sodium. Source presentation: gel. Source route: topical.

Mechanism of action

The mechanism of action of diclofenac sodium in the treatment of actinic keratoses (AK) is unknown.

Pharmacokinetics

Absorption — Diclofenac levels were measured at the end of treatment from 60 patients with AK lesions treated with diclofenac sodium gel in three adequate and well-controlled clinical trials. Each patient was administered 0.5 g of diclofenac sodium gel twice a day for up to 105 days. There were up to three 5 cm x 5 cm treatment sites per patient on the face, forehead, hands, forearm, and scalp. Serum concentrations of diclofenac were, on average, at or below 20 ng/mL.

Distribution — Diclofenac binds tightly to serum albumin.

Metabolism — Biotransformation of diclofenac following oral administration involves conjugation at the carboxyl group of the side chain or single or multiple hydroxylations resulting in several phenolic metabolites, most of which are converted to glucuronide conjugates. Two of these phenolic metabolites are biologically active, however to a much smaller extent than diclofenac. Metabolism of diclofenac following topical administration is thought to be similar to that after oral administration. The small amounts of diclofenac and its metabolites appearing in the plasma following topical administration makes the quantification of specific metabolites imprecise.

Elimination — Diclofenac and its metabolites are excreted mainly in the urine after oral dosing.

Selected passages from the cited U.S. prescribing label. The studies concern the source product and populations named in each passage; they do not establish Walter-product bioequivalence, an approved indication, or the kinetics of another fixed combination. Tables and the full prescribing information remain available in the source.

Source: DailyMed: Diclofenac Sodium — gel

Reference accessed . Label revision: 2026-07-12.

Editorial development perspective

What deserves attention in this formulation.

These notes use the catalogue composition and presentation to frame a technical discussion. They are planning considerations, not tested properties or clinical findings for this product.

The clinical references on this page cover only their named ingredients. These development notes do not resolve the remaining clinical-reference gaps.

About these development notes and source limitations ↗

Assess the base as well as the named ingredients

Listed presentation: Topical ointment.

Compare the proposed base, mixing process, viscosity and ingredient distribution as a complete system. Include the way the product leaves its tube or container in practical development trials. A change from cream to ointment or gel can change the technical questions, so keep each requested presentation in a separate specification.

Carry the exact ingredient form into development

Catalogue wording: “Sodium”.

Use the named ingredient form when requesting material specifications and comparing possible suppliers. Resolve assay, water-content and strength-equivalence conventions before converting a formula into batch quantities. A similarly named salt or hydrate should be assessed as a distinct material choice rather than introduced through a naming shortcut.

Translate the listed strength into a quantitative formula

Strength expressions in this entry include “1.00%”, “5%”, “3%”.

Tie every stated ingredient amount to its intended dosage unit or measure, then distinguish that declared amount from the quantity of raw material needed for a batch. Record any assay or equivalence calculation in the formula. This gives development, purchasing and artwork teams the same strength definition without assigning a patient dose from the catalogue.

Suggested starting point

A practical starting point is to carry the exact ingredient form into development. For this topical ointment brief, agree the target characteristics and a short set of measurable development questions before comparing prototypes or supplier proposals. Keep unresolved clinical claims outside the product specification until supporting evidence is available.

Discuss this product brief

Manufacturing & packaging brief

Plan the topical presentation.

Use this preparation guide for Benzyl Alcohol 1.00% w/w, Diclofenac Sodium 1.00% w/w, Menthol 5% w/w, Mephenesin 5% w/w, Methyl Salicylate 5% w/w, Oleum Lini (Containing Predominantly Linolenic Acid) 3% w/w Topical ointment. These are the decisions to resolve with the technical team before a site, process and commercial scope are confirmed.

Presentation & formulation

Keep cream, ointment and gel requirements distinct. Confirm the full formula, strength-expression basis and intended product specification.

Quality & technical transfer

Ask for review of applicable physical, analytical and microbiological specifications, process-transfer needs and formulation–pack compatibility.

Review the technical documents

Packaging configuration

State fill weight, tube or container material, closure, nozzle and any applicator requirement. List each pack size and artwork version separately.

Explore packaging options

Details to confirm for this record

Full composition
Keep all named components and their individual amounts together in the specification. Ingredient substitutions, omissions and changed ratios require a separate formula and permission review.
Salt and strength wording
Confirm whether the stated amount refers to the named salt, hydrate or equivalent active moiety. Use the agreed expression consistently in the specification, quotation and artwork.
Concentration and pack size
The record includes a concentration or percentage expression. Confirm its complete basis, then specify the finished fill volume or weight separately. Do not treat pack size as the strength.

Quantities, MOQ & lead time

For Benzyl Alcohol 1.00% w/w, Diclofenac Sodium 1.00% w/w, Menthol 5% w/w, Mephenesin 5% w/w, Methyl Salicylate 5% w/w, Oleum Lini (Containing Predominantly Linolenic Acid) 3% w/w Topical ointment (WH-5605), state the pack count and fill weight, target market and reorder forecast. MOQ and lead time depend on the assessed formula, process, components, testing and project readiness; request those terms in writing.

Discuss this manufacturing brief

Explore the context

Build the right manufacturing brief.

Dosage-form capabilitiesTopicals & local formatsTherapeutic navigationDermatology & topical careFull catalogueSearch other compositions

Related catalogue records

Grouped by catalogue navigation labels, not by therapeutic interchangeability or clinical recommendation.

Common questions

Before you request a quotation.

Benzyl Alcohol 1.00% w/w, Diclofenac Sodium 1.00% w/w, Menthol 5% w/w, Mephenesin 5% w/w, Methyl Salicylate 5% w/w, Oleum Lini (Containing Predominantly Linolenic Acid) 3% w/w Topical ointment

What is listed in the catalogue?

The catalogue lists Benzyl Alcohol 1.00% w/w, Diclofenac Sodium 1.00% w/w, Menthol 5% w/w, Mephenesin 5% w/w, Methyl Salicylate 5% w/w, Oleum Lini (Containing Predominantly Linolenic Acid) 3% w/w as topical ointment in its dermatology & topical care navigation area and non-beta-lactam manufacturing stream.

How do you confirm manufacturing availability?

Send Walter your requirement for Benzyl Alcohol 1.00% w/w, Diclofenac Sodium 1.00% w/w, Menthol 5% w/w, Mephenesin 5% w/w, Methyl Salicylate 5% w/w, Oleum Lini (Containing Predominantly Linolenic Acid) 3% w/w Topical ointment. The team reviews the applicable product permission and unit, formulation and equipment fit, testing, packaging and production schedule before confirming the manufacturing scope in writing. Request the relevant product and facility documents with your enquiry.

What do I need for a quotation?

Share the exact composition and strength, topical ointment presentation, target market, initial quantity, preferred pack and timing. Identify whether this is a new product, development brief or transfer.

The quotation must confirm MOQ, inclusions, prerequisites and lead time for the proposed product and site.

What is needed for Indian and export markets?

For India, share the intended brand or institutional supply requirement, pack sizes, initial order quantity and artwork needs for Benzyl Alcohol 1.00% w/w, Diclofenac Sodium 1.00% w/w, Menthol 5% w/w, Mephenesin 5% w/w, Methyl Salicylate 5% w/w, Oleum Lini (Containing Predominantly Linolenic Acid) 3% w/w Topical ointment. Confirm the applicable product permission, manufacturing unit and labelling requirements with the team.

For export, identify each destination country, proposed pack, language and registration or dossier requirements. Ask which product-specific quality and stability documents are available. Container compatibility and destination-market requirements need review; a catalogue record does not establish export registration or a shelf-life commitment.

How do I submit my enquiry?

Use the product-specific enquiry button to carry this composition and dosage form into the form. After a successful submission, a receipt reference confirms that your brief has been saved for review. Use the RFQ checklist to prepare the remaining details.

Technical document review

Which documents can I ask Walter to review?

Ask about manufacturing and packing records, specifications, analytical methods, Certificates of Analysis (COA), stability evidence, the Process Validation Protocol (PVP) and Process Validation Report (PVR). The wider checklist below covers supplier qualification, technical transfer and ongoing supply.

View the full document checklist 14 review areas
Site, licence and audit scope
Manufacturing licence, applicable product permissions, GMP certificates, Site Master File, supplier-qualification questionnaire and relevant audit responses.
Manufacturing, packing and batch release
Master Formula Record (MFR), master packing instructions, Batch Manufacturing Record (BMR), Batch Packing Record (BPR), reconciliation and authorised release records.
Process validation and continued verification
Process Validation Protocol (PVP), Process Validation Report (PVR), process performance qualification documents and continued process verification trends.
Equipment, facilities and utilities
Validation Master Plan (VMP), user requirements, DQ/IQ/OQ/PQ records, calibration and maintenance evidence for relevant equipment and utilities.
Cleaning, carryover and hold times
Cleaning Validation Protocol (CVP), Cleaning Validation Report (CVR), residue limits, recovery studies and applicable clean, dirty and process hold-time studies.
Specifications and analytical evidence
Specifications, Method of Analysis (MOA), Standard Testing Procedure (STP), Certificates of Analysis (COA), analytical validation, verification and method-transfer records.
Stability, packaging and transport
Stability protocols/reports, ongoing stability commitments, pack specifications, approved artwork, compatibility and applicable packaging or transport studies.
Development and technology transfer
Development report, technology-transfer protocol/report, gap assessment, control strategy, critical quality attributes and critical process parameters.
Quality reviews, investigations and changes
Product Quality Review (PQR) / Annual Product Review (APR), deviations, CAPA, change control, OOS/OOT trends, complaints, recalls and relevant SOP/training records.
Material suppliers and impurity risks
API/excipient supplier qualification, traceability, material COAs, relevant origin declarations and impurity risk assessments with supporting tests.
Sterile-product evidence, where applicable
Contamination Control Strategy (CCS), media-fill/aseptic simulation reports, sterilisation and filtration validation, environmental monitoring, sterility/endotoxin and container-closure integrity evidence.
Computerised systems and data integrity
Computerised-system validation, access controls, audit-trail review, backup/restore checks and relevant data-integrity procedures.
Market-specific regulatory support
Applicable dossier sections, API master-file/CEP support, bioequivalence or biowaiver evidence and Certificate of a Pharmaceutical Product (CPP/CoPP), where required and available.
Quality agreement and access arrangements
Quality/technical agreement covering responsibilities, release, changes, subcontracting, investigations, complaints, recalls, audits and document access.

Agree the list for the exact product, site, process, pack, market and project stage. QA confirms what exists, applies and may be shared; some records may require an NDA, redaction or controlled review. See document definitions and review guidance.

Important qualification

This B2B catalogue record is not proof of current approval or confirmation that Benzyl Alcohol 1.00% w/w, Diclofenac Sodium 1.00% w/w, Menthol 5% w/w, Mephenesin 5% w/w, Methyl Salicylate 5% w/w, Oleum Lini (Containing Predominantly Linolenic Acid) 3% w/w Topical ointment is available for sale. It is not prescribing information or patient advice. Any Drugs Rules status, current approval, exemption, applicable unit, licence scope, formulation, claims, brand use, destination-market registration and commercial feasibility require documentary verification and Walter's written confirmation. Read the full regulatory disclaimer.

Composition and classification are taken from Walter's product catalogue. The manufacturing guide helps buyers prepare a technical brief. Clinical references, where shown, describe the cited product and study. Manufacturing guide updated .