Pregabalin + Diclofenac + Methyl Salicylate + Menthol + Capsaicin Gel Technical Specification:
| Product Name: | Pregabalin, Diclofenac Dimethylamine, Methyl Salicylate, Menthol & Capsaicin Gel |
| Brand Name: | Generic |
| Strength: | (8 %+ 5% +10%+ 5%+ 0.035 w/w) |
| Dosage Form: | Gel |
| Route of Administration: | Topical use |
| Packing: | 20gm,30gm |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Neuralgia/ Myalgia |
| Indication: | Pregabalin works by modulating the calcium channel activity of the nerve cells. Diclofenac and Methyl salicylate work by blocking the effect of chemical messengers that cause pain and inflammation. Capsaicin exerts an analgesic effect by desensitizing the nerve endings. Menthol provides a cooling sensation by dilating the blood vessels. Together, pregabalin+ diclofenac+ methyl salicylate+ menthol+ capsaicin helps in providing relief from pain. |
| Storage: | Keep in cool and dark place. Do not freeze. |
Pregabalin 8 %+ Diclofenac 5 %+ Methyl Salicylate 10 %+ Menthol 5 %+ Capsaicin 0.035 %Gel
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Composition:
Pregabalin IP ………………….8% w/w
Methyl Salicylate IP………………10% w/w
Menthol IP…………………………5% w/w
Diclofenac Dimethylamine
Eq. to Diclofenac Sodium IP…….5% w/w
Capsaicin USP ……………………….0.035% w/w
Benzyl Alcohol IP…………………1% w/w
(As a preservative)
Aqueous gel base……………………………q.s.
THERAPEUTIC INDICATIONS:
Pregabalin works by modulating the calcium channel activity of the nerve cells. Diclofenac and Methyl salicylate work by blocking the effect of chemical messengers that cause pain and inflammation. Capsaicin exerts an analgesic effect by desensitizing the nerve endings. Menthol provides a cooling sensation by dilating the blood vessels. Together, pregabalin+ diclofenac+ methyl salicylate+ menthol+ capsaicin helps in providing relief from pain.
CAUTION & SCHEDULE:
Keep out of reach of children.
Replace cap tightly after use
FOR EXTERNAL USE ONLY.
Avoid contact with eye, mucus membrane and broken skin.
Don’t accept if seal is tempered.
SCHEDULE: H DRUG: WARNING: Not sold by retail without prescription of Registered Medical Practitioner only.
Direction of use:
Apply ointment gel and gently rub on affected area, 3-4times daily.
STORAGE:
Storage: Keep in cool and dark place. Do not freeze.