{"active_ingredient":["Active ingredient Miconazole nitrate 2% Miconazole nitrate 2% (external cream)"],"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 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: ▪ applicators: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw away applicator after use. ▪ external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed. children under 12 years of age: ask a doctor"],"effective_time":"20250822","id":"c4195b56-36a3-4584-8d1c-3aed7c4bbbbd","inactive_ingredient":["Inactive ingredients benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol"],"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 right away."],"openfda":{"application_number":["NDA017450"],"brand_name":["Monistat 7 Combination Pack 7-Day Pre-Filled Applicators"],"generic_name":["MICONAZOLE NITRATE"],"is_original_packager":[true],"manufacturer_name":["Insight Pharmaceuticals LLC"],"package_ndc":["63736-023-15"],"product_ndc":["63736-023"],"product_type":["HUMAN OTC DRUG"],"rxcui":["998540","998541","1536610","1854816"],"spl_id":["c4195b56-36a3-4584-8d1c-3aed7c4bbbbd"],"spl_set_id":["9b1ac735-9b18-48c2-86dc-93d07157d5e5"]},"other_safety_information":["Other information do not use if not use if seal over tube opening has been punctured do not purchase if carton is open store at 20° - 25°C (68° to 77°F) Keep this carton for future refeence. It contains important information."],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - Kit Carton 7- DAY TREATMENT NEW LOOK! MONISTAT ® 7 Miconazole Nitrate Vaginal Cream (2%) – Vaginal Antifungal COMBINATION PACK 7- DAY TREATMENT ____________ CREAM Cream with 7 Disposable Applicators plus External Cream for Itch Relief Net Wt. 1.59 oz (45 g) Tube + 0.32 oz (9 g) Tube + 7 Disposable Applicators 7- DAY TREATMENT NEW LOOK! MONISTAT® 7 Miconazole Nitrate Vaginal Cream (2%) – Vaginal Antifungal COMBINATION PACK 7- DAY TREATMENT ____________ CREAM Cream with 7 Disposable Applicators plus External Cream for Itch Relief Net Wt. 1.59 oz (45 g) Tube + 0.32 oz (9 g) Tube + 7 Disposable Applicators"],"pregnancy_or_breast_feeding":["If pregnant or breast feeding, ask a health professional before use."],"purpose":["Purpose Vaginal antifungal Vaginal antifungal"],"questions":["Questions? If you have any questions or comments, please call 1- 877-666- 4782"],"set_id":"9b1ac735-9b18-48c2-86dc-93d07157d5e5","spl_product_data_elements":["Monistat 7 Combination Pack 7-Day Pre-Filled Applicators Miconazole Nitrate Miconazole Nitrate Miconazole Nitrate Miconazole Nitrate Miconazole Benzoic Acid Cetyl Alcohol Isopropyl Myristate Polysorbate 60 Potassium Hydroxide Propylene Glycol Water Stearyl Alcohol Miconazole Nitrate Miconazole Nitrate Miconazole Nitrate Miconazole Benzoic Acid Cetyl Alcohol Isopropyl Myristate Polysorbate 60 Potassium Hydroxide Propylene Glycol Water Stearyl Alcohol"],"spl_unclassified_section":["MONISTAT 7 COMBINATION PACK 7-DAY PRE-FILLED APPLICATORS- miconazole nitrate Insight Pharmaceuticals ---------- MONISTAT ® 7 Combination Pack Drug Facts",""],"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":"6","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 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 disease (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 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 disease (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"]}