{"active_ingredient":["ACTIVE INGREDIENT Miconazole nitrate 2% (100 mg in each applicator) Miconazole nitrate 2% (as external cream)"],"dosage_and_administration":["DOSAGE & ADMINISTRATION • before using this product read the enclosed consumer information leaflet for complete instructions • adults and children 12 years of age and over: • applicator: insert one applicatorful into the vagina at bedtime for 7 nights in a row • external cream: squeeze a small amount of cream onto your fingertip. Gently apply the cream onto the itchy, irritated skin outside the vagina. Use daily for up to 7 days as needed • children under 12 years of age: ask a doctor"],"effective_time":"20220430","id":"dde311f0-0ee5-e416-e053-2a95a90a860b","inactive_ingredient":["INACTIVE INGREDIENT benzoic acid, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water"],"indications_and_usage":["USES • treats repeat vaginal yeast infections • relieves external itching and irritation due to a repeat 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":{},"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 45 g Tube Carton Miconazole Nitrate Vaginal Cream 2% Vaginal Antifungal 7 Day Vaginal Cream Relieves external vulvar itching and irritation associated with a yeast infection CURES MOST VAGINAL YEAST INFECTIONS NET WT 1.59 OZ (45g) Unit Carton"],"pregnancy_or_breast_feeding":["IF PREGNANT OR BREAST FEEDING, ask a health professional before use."],"purpose":["PURPOSE Vaginal antifungal"],"questions":["QUESTIONS 1-800-922-1038"],"set_id":"7257b2ae-c0b2-520a-f83d-cf1f6d1343ee","spl_product_data_elements":["Miconazole Nitrate Miconazole Nitrate BENZOIC ACID BUTYLATED HYDROXYANISOLE MINERAL OIL PEG-5 OLEATE PEGOXOL 7 STEARATE WATER MICONAZOLE NITRATE MICONAZOLE"],"storage_and_handling":["OTHER INFORMATION • do not use if seal over tube opening has been punctured or cannot be seen • store at room temperature 15°-30°C (59°-86°F). Avoid heat over 30°C or 86°F."],"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 medication warfarin, because bleeding or bruising may occur. When using this product • do not use tampons, douches, spermicides, or other vaginal products • do not have vaginal intercourse • condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs) 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"]}