Properties
What is it?
Composition: Metronidazole USP - 1.0% w/w ; Gel base - q.s. Description: The gel contains 1% Metronidazole, an antibiotic used to treat certain skin conditions known as rosacea (adult acne), which is an inflammatory skin disease causing facial swelling, redness, and dry lesions on the face. The preparation has the ability to reduce redness, swelling, and pimples caused by rosacea. The gel reduces swelling (inflammation) by stopping the growth of bacteria. Pharmacological Properties: Elegant Rose Gel is an antibiotic. Metronidazole is believed to treat rosacea by reducing swelling (inflammation). Indication: Elegant Rose Gel is indicated for topical use for the treatment of inflammatory papules and pustules of rosacea. Contraindications: Elegant Rose Gel is contraindicated in individuals with a history of hypersensitivity to metronidazole or other components of the preparation. Instructions for Use and Dosage: Wash the affected skin before applying Elegant Rose Gel. Apply Elegant Rose Gel to the affected area and rub gently. Cosmetics can be used after 5 minutes, wait for the medication to dry. Possible Side Effects: Seek immediate medical attention if you have signs of an allergic reaction: hives; difficulty breathing; swelling of the face, lips, tongue, or throat. Call your doctor immediately if you experience flushing or burning while using Elegant Rose Gel. Common side effects may include: mild flushing or burning sensation; numbness or tingling in the hands or feet; mild skin redness or irritation; dry, rough, or peeling skin; nausea; or a metallic taste in the mouth. Special Instructions: Tell your doctor and pharmacist if you are allergic to metronidazole or any ingredient in this external use preparation. Ask your pharmacist for a list of ingredients. Tell your doctor and pharmacist what prescription medications, vitamins, dietary supplements, and herbal products you are taking or plan to take. Be sure to list the following medications: anticoagulants (blood thinners) such as warfarin (Coumadin, Jantoven). Tell your doctor if you have or have ever had a central nervous system disease (spinal cord or brain diseases) or blood disease. Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. If you become pregnant while using metronidazole, contact your doctor. Warnings: Systemic absorption of metronidazole has been demonstrated after topical use of metronidazole. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with topical use of metronidazole. If significant diarrhea develops, discontinue use of the gel. Do not use the gel if you have had an allergic reaction to metronidazole, clindamycin, adapalene, or any ingredient in the gel. Storage Conditions: Store at not more than 25°C in a dry place. Protect from heat and direct sunlight. Expiration Date: 3 years from the date of manufacture. Dosage Form: 30g Elegant Rose Gel in a laminated tube, packed in a box with a patient information leaflet. Dispensing Rule: Pharmaceutical Product Group III, Over-the-counter Manufacturer: Elegant Cosmetics, India
