Properties
What is it?
Composition: Metronidazole USP-1.0% w-w; Gel base-q.s. Indication: The gel contains 1% Metronidazole, which is an antibiotic used to treat certain skin conditions known as rosacea (adult acne), which is an inflammatory skin disease that causes 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 bacterial growth. 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: Before using Elegant Rose Gel, the affected skin needs to be washed. Elegant Rose Gel should be applied to the affected area and gently rubbed. Cosmetics can be used after 5 minutes, wait for the medication to dry. Possible Side Effects: Seek immediate medical attention if the patient has 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 sensation while using Elegant Rose Gel. General side effects may include: mild flushing or burning sensation; numbness or tingling sensation in the hands or feet; mild skin redness or irritation; dry, rough, or peeling skin; nausea; or a metallic taste in the mouth. If any side effects occur, including those not listed in this instruction, consult your doctor or pharmacist. Special Instructions: Inform your doctor and pharmacist if the patient is allergic to metronidazole or any ingredient in this external use preparation. Ask the pharmacist for a list of ingredients. Inform your doctor and pharmacist about any prescription medications, vitamins, dietary supplements, and herbal products the patient is taking or plans to take. The patient should ensure they have listed the following medications: anticoagulants (blood thinners) such as warfarin (Coumadin, Jantoven). Inform your doctor if the patient has or has ever had a central nervous system disease (spinal cord or brain diseases) or blood disease. Inform your doctor if the patient is pregnant, planning to become pregnant, or is breastfeeding. If the patient becomes pregnant while using metronidazole, consult 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. The gel should not be used if the patient has had an allergic reaction to metronidazole, clindamycin, adapalene, or any ingredient in the gel. Storage: Store at no more than 25C in a dry place, inaccessible to children. 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, placed in a box with instructions for use. Dispensing Category: Pharmaceutical Product Group III, available without a prescription. Manufacturer: Elegant Cosmetics Pvt. Ltd., India.