{"active_ingredient":["Active Ingredient Clotrimazole"],"dosage_and_administration":["Directions Children under 12: Ask a physician. Adults and children 12 years and older: femmesil may be used topically (outside the vaginal area) or intravaginally. Squeeze a small amount of ointment onto fingertip. Apply 2 to 3 times daily for up to 3 days or longer as needed. Store at room temperature."],"effective_time":"20250825","id":"3d36794a-07d1-860c-e063-6294a90a6e8f","inactive_ingredient":["Inactive Ingredients beeswax, coconut oil (organic), cottonseed oil*, jojoba oil, magnesium oxide, MCT oil, peppermint oil, silver stearate, tea tree oil, vegetable stearic acid (naturally sourced)*, zinc oxide *may contain this ingredient"],"indications_and_usage":["Uses Treats vaginal yeast infections."],"keep_out_of_reach_of_children":["Keep out of reach of children."],"openfda":{"application_number":["M005"],"brand_name":["femmesil Ultra Therapy"],"generic_name":["CLOTRIMAZOLE"],"is_original_packager":[true],"manufacturer_name":["Aidance Scientific, Inc."],"nui":["N0000175487","M0002083"],"package_ndc":["24909-050-28"],"pharm_class_cs":["Azoles [CS]"],"pharm_class_epc":["Azole Antifungal [EPC]"],"product_ndc":["24909-050"],"product_type":["HUMAN OTC DRUG"],"route":["TOPICAL"],"rxcui":["2722226"],"spl_id":["3d36794a-07d1-860c-e063-6294a90a6e8f"],"spl_set_id":["3d36794a-07d0-860c-e063-6294a90a6e8f"],"substance_name":["CLOTRIMAZOLE"],"unii":["G07GZ97H65"]},"other_safety_information":["If swallowed, call poison control or seek medical help."],"package_label_principal_display_panel":["Tube"],"pregnancy_or_breast_feeding":["If pregnant or breastfeeding , ask a health professional before use."],"purpose":["Purpose Vaginal Antifungal"],"set_id":"3d36794a-07d0-860c-e063-6294a90a6e8f","spl_product_data_elements":["femmesil Ultra Therapy Clotrimazole CLOTRIMAZOLE CLOTRIMAZOLE MAGNESIUM OXIDE JOJOBA OIL COTTONSEED OIL PEPPERMINT OIL COCONUT OIL BEESWAX PALM OIL ZINC OXIDE SILVER STEARATE TEA TREE OIL STEARIC ACID"],"spl_unclassified_section":["Questions? 401-432-7750 or www.aidance.com"],"version":"1","warnings":["Warnings For vaginal use only. Do not use if you have never had a vaginal yeast infection diagnosed by a doctor; if you have a fever (higher than 100° F), pain in the lower abdomen, back, either shoulder, or a foul-smelling vaginal discharge.You should see a doctor for treatment of these symptoms. 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 or diaphragms may be damaged and fail to prevent sexually transmitted disease or pregnancy. • 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 improve in 3 days; symptoms last more than 7 days; you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting or a foul-smelling vaginal discharge. If pregnant or breastfeeding , ask a health professional before use. Keep out of reach of children. If swallowed, call poison control or seek medical help."]}