Fistulin Oil

Fistulin Oil — Trade/Clinic Specification (India)

AYUSH-GMP • 15 ml / 30 ml • Professional Use • Low Flammability (oil base)

Product Overview

Fistulin Oil is a proprietary homeopathic formulation prepared under AYUSH-GMP. This page summarizes label indications, composition, packaging, quality documentation, and logistics for professional supply.

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Label Indications (verbatim)

• Fistula
• Fissures
• Fistula ulcer of long standing

Use consistent with the product label and applicable regulations.

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Dosage (label)

• Application: Apply on the affected parts twice daily preferably before bed time, or as advised by the physician

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Composition & Potency

Actives (per 5 ml label):

• Silicea 200C — 0.015ml
• Calcarea fluorica 200C — 0.015ml

Vehicle: Arachis Oil (peanut oil) qs
Alcohol content: 0.54% v/v
Manufacturing standard: Prepared per HPI in an AYUSH-GMP facility.

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Packs & Trade Data

Pack size	SKU	GTIN-13 / EAN
15 ml	FISO-015	________________
30 ml	FISO-030	________________

Label elements present: Product name, composition, potency, batch no., Mfg/Exp dates, storage, cautionary statements, manufacturer details.

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Case Pack & Carton Logistics

Pack size	Units / master carton	Carton dimensions (cm)	Gross wt. (kg)
15 ml	48	__ × __ × __	__.__
30 ml	48	__ × __ × __	__.__

• Palletisation: Specs available on request
• HSN: 3004.90 (confirm at dispatch)
• Ethanol (v/v): 0.54% (per label)

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Storage & Handling

• Store below 25 °C, protected from light.
• Keep container tightly closed; keep away from strong odours and heat sources.
• Low flammability (minimal ethanol, oil-based formulation).
• Keep out of reach of children.

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Regulatory & Compliance

• AYUSH-GMP: Yes
• Manufacturing documentation: Master formula, batch manufacturing records, change control retained per QMS
• Label compliance: As per Drugs and Cosmetics rules (India); includes mandatory cautionary statements and storage
• Intended audience: Registered practitioners, licensed clinics/hospitals, authorized pharmacies/dispensaries

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Quality Control & Documentation

Batch documentation available to professional customers (on request / behind login):

• COA (Certificate of Analysis) per batch
• MSDS/SDS
• Stability summary (where applicable)
• Traceability documentation

Routine QC (summary):

• Identity checks (source verification, Silicea authentication)
• In-process controls per HPI/QMS
• Finished product checks: organoleptic, ethanol % (v/v), oil quality, label accuracy, traceability

Access documentation via the professional portal or request from QA with batch number.

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Supply & Dispatch (Logistics)

• Cut-off for same-day dispatch (stocked lines): 14:00 IST
• Typical dispatch window: 1–5 business days India-wide (route dependent)
• Couriers: XpressBees, BlueDart (routing may vary)
• Transport packaging: Shock-resistant outer; standard handling

For shipment coordination and documentation support, contact the professional/QA desk with your batch number and destination details.

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Marketing & Professional Materials

Available to professional customers (on request / behind login):

• High-resolution pack images (15 ml / 30 ml)
• Product specification sheet (PDF)
• Clinical reference guide for fistula and fissure management
• Application technique guide
• Storage & handling poster (A4)
• Safety data sheet

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Frequently Asked (Trade)

• How do I obtain a COA/MSDS? Provide the batch number to the QA desk or use the professional portal.
• What shelf-life do shipments carry? Shipments typically maintain ≥80% of labeled shelf-life remaining unless otherwise specified.
• Can I confirm GTIN/EAN for cataloguing? See the Packs & Trade Data table above; QA can re-confirm if needed.
• Is this for topical use only? Yes, this is a topical oil formulation to be applied on affected parts, preferably before bed time.
• Can this be used with oral Fistulin? Professional judgment required; combination therapy (oral Fistulin once weekly + topical Fistulin Oil) may be considered for comprehensive management.
• What is the base oil? Arachis oil (peanut oil); patients with peanut allergies should be counseled appropriately.

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Document Information

Last Updated: October 23, 2025
Document Version: 1.0
Review Date: May 23, 2026

Professional Contacts (documentation & QA):

• QA/Docs: docs@pbmp.in (include product + batch no.)
• General Information: info@pbmp.in

Disclaimer: This document is intended for healthcare professionals and authorized trade customers. It does not constitute medical advice. All information aligns with product labeling and applicable regulations. Use per professional judgment and local law.