{"active_ingredient":["ACTIVE INGREDIENTS MICONOZOLE NITRATE 2% (100 MG IN EACH APPLICATOR)"],"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 OR OVER: APPLICATOR: INSERT 1 APPLICATOR INTO THE VAGINA AT BEDTIME FOR 7 NIGHTS IN A ROW. THROW APPLICATOR AWAY AFTER USE. EXTERNAL CREAM: 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":"20240904","id":"214e6edc-8028-e8d5-e063-6394a90af7a0","inactive_ingredient":["INACTIVE INGREDIENTS BENZOIC ACID, BUTYLATED HYDROXYANISOLE, GLYCERINE STEARATE, MINERAL OIL, PEGLICOL 5 OLEATE, PEGOXOL 7 STEARATE, PURIFIED WATER"],"indications_and_usage":["USES TREATS VAGINAL YEAST INFECTIONS RELIEVES EXTERNAL ITCHING AND URINATION DUE TO VAGINAL YEAST INFECTION"],"keep_out_of_reach_of_children":["Keep out of reach of children If swallowed get medical help or contact Poison Control Center right away."],"openfda":{"application_number":["M005"],"brand_name":["VAGISTEN-V 7 DAY"],"generic_name":["MICONAZOLE NITRATE"],"is_original_packager":[true],"manufacturer_name":["OPMX LLC"],"package_ndc":["69729-612-01","69729-612-05"],"product_ndc":["69729-612"],"product_type":["HUMAN OTC DRUG"],"route":["VAGINAL"],"rxcui":["998540"],"spl_id":["214e6edc-8028-e8d5-e063-6394a90af7a0"],"spl_set_id":["a5bfa501-5ae1-4434-bc31-995d0665b99e"],"substance_name":["MICONAZOLE NITRATE"],"unii":["VW4H1CYW1K"],"upc":["0856828008212"]},"other_safety_information":["OTHER INFORMATION DO NOT USE IF SEAL TUBE OPENING HAS BEEN PUNCTURED DO NOT PURCHASE IF CARTON OPEN STORE AT 20° - 25°C (68°F - 77°F)"],"package_label_principal_display_panel":["0-UC_VAGISTEN-V CREMA 2pct_front 0-UC_VAGISTEN-V CREMA 2pct_back"],"purpose":["PURPOSE VAGINAL ANTIFUNGAL"],"set_id":"a5bfa501-5ae1-4434-bc31-995d0665b99e","spl_product_data_elements":["VAGISTEN-V 7 DAY MICONAZOLE NITRATE BENZOIC ACID BUTYLATED HYDROXYANISOLE GLYCERYL MONOSTEARATE MINERAL OIL PEG-5 OLEATE PEGOXOL 7 STEARATE WATER MICONAZOLE NITRATE MICONAZOLE"],"version":"2","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 FIRST TIME LOWER ABDOMINAL, BACK OR SHOULDER PAIN, FEVER, CHILLS, NASEA, 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 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 HAVE TAKEN A PRESCRIPTION BLOOD THINNING MEDICINE, SUCH AS WARFARIN, BECAUSE BLEEDING OR BRUISING MAY OCCUR. WHEN USING THIS PRODUCT DO NOT USE TAMPONS, DOUCHES, SPERMACIDES OR OTHER VAGINAL PRODUCTS. CONDOMS AND DIAPHRAGMS MAY BE DAMAGED OR FAIL TO PREVENT PREGNANCY OR SEXUALLY TRANSMITTED DISEASES (STDS). DO NOT HAVE VAGINAL INTERCOURSE MILD INCREASE IN VAGINAL BURNING, ITCHING OR IRRITATION MAY OCCUR. 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 HIVESS, ABDOMINAL PAIN, FEVER, CHILLS, NAUSEA, VOMITING OR FOUL-SMELLING DISCHARGE IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE."]}