- Approval Id
- 4b9c4592d3c8e7d5
- Drug Name
- ROZEX GEL 0.75%
- Product Name
- ROZEX GEL 0.75%
- Approval Number
- SIN08453P
- Approval Date
- 1995-11-30
- Registrant
- GALDERMA SINGAPORE PRIVATE LIMITED
- Licence Holder
- GALDERMA SINGAPORE PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- GEL
- Dosage
- <p><strong>DOSAGE AND ADMINISTRATION</strong><br>
Apply and rub in a thin film of ROZEX twice daily, morning and evening, to the entire affected areas after washing. Significant therapeutic results should be noticed within three weeks. Clinical studies have demonstrated continuing improvement through nine weeks of therapy. Areas to be treated should be cleansed before application of ROZEX. Patients may use cosmetics after application of ROZEX.</p>
- Route Of Administration
- TOPICAL
- Indication Info
- <p><strong>INDICATIONS AND USAGE</strong><br>
ROZEX Gel is indicated for topical application in the treatment of inflammatory papules, pustules and erythema of rosacea.</p>
- Contraindications
- <p><strong>CONTRA-INDICATIONS</strong><br>
Rozex Gel is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other Ingredients of the formulation.<br>
Metronidazole must not be used in patients with Cockayne syndrome. Cases of severe hepatotoxicity/acute hepatic failure, including cases with a fatal outcome with very rapid onset after treatment initiation in patients with Cockayne syndrome have been reported with products containing metronidazole for systemic use.</p>
- Atc Code
- D06BX01
- Atc Item Name
- metronidazole
- Pharma Manufacturer Name
- GALDERMA SINGAPORE PRIVATE LIMITED
