{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-02", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "MONISTAT TIOCONAZOLE 1 TIOCONAZOLE TIOCONAZOLE TIOCONAZOLE BUTYLATED HYDROXYANISOLE MAGNESIUM ALUMINUM SILICATE PETROLATUM" ], "spl_unclassified_section": [ "Drug Facts", "Other i nformation this product is a 1-dose treatment. Most women do not get complete relief of their symptoms in just one day. Most women get some improvement in one day and complete relief of symptoms within 7 days. if you have questions about vaginal yeast infections, consult your doctor store at 20°-25°C (68°-77°F) see end flap of carton for lot number and expiration date" ], "active_ingredient": [ "Active ingredient (in each applicator) Tioconazole 300 mg (6.5%)" ], "purpose": [ "Purpose Vaginal antifungal" ], "indications_and_usage": [ "Uses treats vaginal yeast infections" ], "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 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 right away (1-800-222-1222)." ], "do_not_use": [ "Do not use if you have never had a vaginal yeast infection diagnosed by a doctor." ], "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" ], "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" ], "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 ." ], "pregnancy_or_breast_feeding": [ "If pregnant or breast- feeding ask a health professional before use" ], "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 (1-800-222-1222)." ], "dosage_and_administration": [ "Directions before using this product read the enclosed brochure and instructions on foil packet for complete directions and information adults and children 12 years of age and over: ○ open the foil packet just before use and remove purple cap ○ insert entire content of applicator into the vagina at bedtime. Throw applicator away after use. children under 12 years of age: ask a doctor." ], "inactive_ingredient": [ "Inactive ingredients butylated hydroxyanisole, magnesium aluminum silicate, white petrolatum" ], "questions": [ "Questions? 1-877-666-4782" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL MONISTAT® Tioconazole Ointment 6.5% VAGINAL ANTIFUNGAL Net Wt. 0.16 OZ (4.6 g) PREFILLED APPLICATOR Monistat Tioconazole" ], "set_id": "587e42b4-cbdc-4a03-afae-f9e5e6605937", "id": "5aafb76b-fbad-b204-e063-6294a90ae85b", "effective_time": "20260904", "version": "2", "openfda": { "application_number": [ "ANDA075915" ], "brand_name": [ "MONISTAT TIOCONAZOLE 1" ], "generic_name": [ "TIOCONAZOLE" ], "manufacturer_name": [ "Insight Pharmaceuticals LLC" ], "product_ndc": [ "63736-413" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "TOPICAL" ], "substance_name": [ "TIOCONAZOLE" ], "rxcui": [ "198380", "1661176" ], "spl_id": [ "5aafb76b-fbad-b204-e063-6294a90ae85b" ], "spl_set_id": [ "587e42b4-cbdc-4a03-afae-f9e5e6605937" ], "package_ndc": [ "63736-413-01" ], "is_original_packager": [ true ], "nui": [ "N0000175487", "M0002083" ], "pharm_class_epc": [ "Azole Antifungal [EPC]" ], "pharm_class_cs": [ "Azoles [CS]" ], "unii": [ "S57Y5X1117" ] } } ] }