{"active_ingredient":["Active ingredient Miconazole nitrate USP 2% (100 mg in each applicatorful)"],"ask_doctor":["Ask a doctor before use if you have vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to the human immunodeficiency virus (HIV) that causes AIDS"],"ask_doctor_or_pharmacist":["Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur"],"do_not_use":["Do not use if you have never had a vaginal yeast infection diagnosed by a doctor"],"dosage_and_administration":["Directions before using this product read the enclosed consumer information leaflet for complete directions and information adults and children 12 years of age and over: applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator after use. use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to itchy, irritated skin outside the vagina (vulva). Use 2 times daily for up to 7 days as needed. children under 12 years of age: ask a doctor"],"effective_time":"20250527","id":"362a2e22-e1bb-aae7-e063-6394a90a33f0","inactive_ingredient":["Inactive ingredients benzoic acid (0.20%) as a preservative, butylated hydroxytoluene, mineral oil, oleoyl polyoxylglyceride, PEG-6-32 stearate/glycol stearate, and purified water."],"indications_and_usage":["Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection"],"keep_out_of_reach_of_children":["Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"openfda":{"application_number":["ANDA074444"],"brand_name":["Miconazole Nitrate"],"generic_name":["MICONAZOLE NITRATE"],"is_original_packager":[true],"manufacturer_name":["Sun Pharmaceutical Industries, Inc."],"package_ndc":["51672-2035-6","51672-2035-7"],"product_ndc":["51672-2035"],"product_type":["HUMAN OTC DRUG"],"route":["VAGINAL"],"rxcui":["998540"],"spl_id":["362a2e22-e1bb-aae7-e063-6394a90a33f0"],"spl_set_id":["6b34d0be-4bcd-4dff-b732-7fbd46765019"],"substance_name":["MICONAZOLE NITRATE"],"unii":["VW4H1CYW1K"],"upc":["0351672203566"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 45 g Tube Carton CURES most vaginal YEAST INFECTIONS Relieves associated external itching and irritation NDC 51672-2035-6 7 Day Treatment 7 Day Vaginal Cream Miconazole Nitrate Vaginal Cream USP (2%) (Miconazole Nitrate 100 mg per application) Vaginal Antifungal One 45 g (1.5 oz) tube of Miconazole Nitrate Vaginal Cream USP (2%) & 1 Reusable Applicator Consumer Information Leaflet Enclosed PRINCIPAL DISPLAY PANEL - 45 g Tube Carton"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Vaginal antifungal"],"questions":["Questions? call 1-866-923-4914"],"set_id":"6b34d0be-4bcd-4dff-b732-7fbd46765019","spl_product_data_elements":["Miconazole Nitrate Miconazole Nitrate BUTYLATED HYDROXYTOLUENE MINERAL OIL WATER BENZOIC ACID MICONAZOLE NITRATE MICONAZOLE"],"spl_unclassified_section":["Drug Facts","Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532"],"stop_use":["Stop use and ask a doctor if symptoms do not get better in 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge."],"storage_and_handling":["Other information do not purchase if carton is opened do not use if seal over tube opening has been punctured or is not visible store at 20° to 25°C (68° to 77°F) see carton or tube crimp for lot number and expiration date"],"version":"4","warnings":["Warnings For vaginal use only Do not use if you have never had a vaginal yeast infection diagnosed by a doctor Ask a doctor before use if you have vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to the human immunodeficiency virus (HIV) that causes AIDS Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur When using this product do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur if you do not get complete relief ask a doctor before using another product Stop use and ask a doctor if symptoms do not get better in 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away."],"when_using":["When using this product do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur if you do not get complete relief ask a doctor before using another product"]}