Potassium Nitrate + Sodium Fluoride Gel
Potassium Nitrate IP 5% w/w + Sodium Monofluorophosphate IP 0.7% w/w Gel · Dental, Oral Care
GEL PRESENTATION:
Product Profile
Potassium Nitrate + Sodium Fluoride Gel is a dental desensitizing and anticavity formulation indicated for sensitive teeth and caries prevention. As a premier WHO-GMP certified pharmaceutical manufacturer in Baddi, Saar Biotech produces this gel using controlled homogenization.
DCGI Approved
Comprehensive documentation and CDSCO support for rapid market entry in India.
Fast Turnaround
30-45 days lead time for new batches with state-of-the-art logistics.
Pan-India Supply & Contract Manufacturing
Clinical Overview & Therapeutic Class
This gel belongs to the Gels and Dental categories within the Dental therapeutic segment.
Saar Biotech manufactures this gel from our manufacturing facility in Baddi.
Pan-India Supply & Contract Manufacturing
The Saar Biotech Advantage
At Saar Biotech, we manufacture this gel using a precision-controlled manufacturing process that ensures uniform API distribution.
- Two-API Uniformity: Homogeneous dispersion of both actives.
- Viscosity Consistency: Ensures easy application.
- pH-Optimised Base: Compatible with oral tissues.
- Tube Filling Precision: Automated filling ensures accurate weight.
Pan-India Supply & Contract Manufacturing
Key Indications & Usage
This gel is manufactured by Saar Biotech for the following clinically recognised indications:
- Dentinal Hypersensitivity: Relief from sensitive teeth
- Caries Prevention: Strengthening of tooth enamel
- Fluoride Therapy: Prevention of dental decay
Pan-India Supply & Contract Manufacturing
Mechanism of Action & Formulation Integrity
Potassium Nitrate blocks nerve transmission in the teeth. Sodium Fluoride strengthens tooth enamel and prevents decay.
Manufacturing Integrity
- Two-API Compatibility: Both actives remain stable in the gel base.
- Preservation System: Maintains microbiological integrity.
Pan-India Supply & Contract Manufacturing
B2B & Contract Manufacturing Details
Saar Biotech offers Contract Manufacturing for this gel from our semi-solid manufacturing facility in Baddi, Himachal Pradesh.
- Facility: Semi-solid manufacturing lines with planetary mixer homogenizers and automated tube filling.
- Capacity: Scalable from pilot batches to large commercial runs.
- Quality Lab: GLP-certified in-house QC with HPLC/Assay, pH metres, and viscometers.
- Turnaround: 30–45 working days for new orders; 20–25 working days for repeat partners.
- Packaging: 50gm and 100gm laminated tubes with custom mono-carton.
- MOQ: 5,000–10,000 tubes per SKU.
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Storage & Handling Guidelines
- Sealed Tube Storage: Store below 30°C in a cool, dry location away from direct sunlight. Do not freeze.
- In-Use Handling: Replace the cap firmly after each use.
- Application Precautions: For dental use only. Avoid swallowing.
Pan-India Supply & Contract Manufacturing
Quality Control & Compliance
Every batch is released only after completing the following analytical protocol:
- Assay: Confirmation of Potassium Nitrate and Sodium Fluoride content.
- pH Testing: Verification of pH within specification range.
- Viscosity Testing: Confirmation of batch-to-batch consistency.
- Microbial Limit Test (MLT): Confirms total aerobic count and absence of specified pathogens.
- Certificate of Analysis (COA): Issued with every B2B consignment.
Pan-India Supply & Contract Manufacturing
Side Effects & Safety Profile
Common Side Effects: Rare; mild local irritation.
Contraindications: Known hypersensitivity to any component. Avoid swallowing.
Precautions: Supervise use in children. For dental use only.
For B2B manufacturing enquiries, third-party contracts, or to request complete product details for Potassium Nitrate + Sodium Fluoride Gel, please use the enquiry form below.
Pan-India Supply & Contract Manufacturing
Clinical Q&A for Potassium Nitrate + Sodium Fluoride Gel
Technical data on bioavailability, pediatric dosing protocols, and therapeutic efficacy for healthcare professionals.
What are the clinical indications for Potassium Nitrate + Sodium Fluoride Gel?
How does this gel work for sensitive teeth?
What is the standard application protocol?
What are the key precautions?
What are the common side effects?
B2B Manufacturing Guide for Potassium Nitrate + Sodium Fluoride Gel
Detailed insights on MOQs, lead times, and regulatory support for contractmanufacturing partners.
