MedPath
HSA Approval

ROZEX GEL 0.75%

SIN08453P

ROZEX GEL 0.75%

ROZEX GEL 0.75%

November 30, 1995

GALDERMA SINGAPORE PRIVATE LIMITED

GALDERMA SINGAPORE PRIVATE LIMITED

Regulatory Information

GALDERMA SINGAPORE PRIVATE LIMITED

GALDERMA SINGAPORE PRIVATE LIMITED

Therapeutic

Prescription Only

Formulation Information

GEL

**DOSAGE AND ADMINISTRATION** 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.

TOPICAL

Medical Information

**INDICATIONS AND USAGE** ROZEX Gel is indicated for topical application in the treatment of inflammatory papules, pustules and erythema of rosacea.

**CONTRA-INDICATIONS** Rozex Gel is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other Ingredients of the formulation.

D06BX01

metronidazole

Manufacturer Information

GALDERMA SINGAPORE PRIVATE LIMITED

LABORATOIRES GALDERMA

Active Ingredients

METRONIDAZOLE

0.75%

Metronidazole

Documents

Package Inserts

ROZEX GEL PI.pdf

Approved: December 20, 2021

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ROZEX GEL 0.75% - HSA Approval | MedPath