{"active_ingredient":["Active ingredient Miconazole nitrate, USP 2% (100 mg in each applicator)"],"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: o applicator: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator after use. o 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":"20260708","id":"0a501517-fd9e-461f-9aec-bcf5905c0091","inactive_ingredient":["Inactive ingredients benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, 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":["ANDA074164"],"brand_name":["Miconazole 7"],"generic_name":["MICONAZOLE NITRATE"],"manufacturer_name":["Preferred Pharmaceuticals Inc."],"original_packager_product_ndc":["0904-7734"],"package_ndc":["68788-8661-4"],"product_ndc":["68788-8661"],"product_type":["HUMAN OTC DRUG"],"route":["VAGINAL"],"rxcui":["998540"],"spl_id":["0a501517-fd9e-461f-9aec-bcf5905c0091"],"spl_set_id":["85a52081-d9cc-44f0-a8d3-851a45c4eb10"],"substance_name":["MICONAZOLE NITRATE"],"unii":["VW4H1CYW1K"]},"package_label_principal_display_panel":["Principal display panel Compare to the active ingredient in Monistat® 7 Vaginal Cream* Miconazole 7 Miconazole Nitrate Vaginal Cream, USP 2% (Miconazole Nitrate 100 mg per applicator) 2% Vaginal Antifungal Cures most vaginal yeast infections Relieves associated external itching and irritation 7 day vaginal cream (1 tube) with 1 reusable applicator NET WT OZ (g) Tube *This product is not affiliated with, manufactured by, or produced by the makers or owners of Monistat®. Distributed by: MAJOR® PHARMACEUTICALS Indianapolis, IN 46268 www.majorpharmaceuticals.com Miconazole Nitrate Vaginal Cream 2%"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Vaginal antifungal"],"questions":["Questions? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST"],"set_id":"85a52081-d9cc-44f0-a8d3-851a45c4eb10","spl_product_data_elements":["Miconazole 7 Miconazole Nitrate MICONAZOLE NITRATE MICONAZOLE BENZOIC ACID BUTYLATED HYDROXYANISOLE MINERAL OIL APRICOT KERNEL OIL PEG-6 ESTERS PEGOXOL 7 STEARATE WATER"],"spl_unclassified_section":["Drug Facts","Other information • to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use • do not use if foil seal on tube opening is broken or missing • do not purchase if carton is open • store at room temperature 20°to 25°C (68°to 77°F) • before using any medication, read all label direction. Keep carton, it contains important information. • Relabeled By: Preferred Pharmaceuticals Inc."],"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"],"version":"3","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."]}