{"active_ingredient":["Active ingredients Clotrimazole, USP 1% (50 mg in each applicatorful)","Active ingredients Clotrimazole, USP 1% (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 the human immunodeficiency virus (HIV) that causes AIDS"],"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 educational brochure for complete directions and information • adults and children 12 years of age and over: o vaginal cream: insert one applicatorful of cream into the vagina at bedtime for 7 days in a row. Wash applicator after each use. o 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. Use 2 times daily for up to 7 days as needed. • children under 12 years of age: ask a doctor"],"effective_time":"20240109","id":"a8a450d3-9fcb-4b35-900f-2834ecb29a07","inactive_ingredient":["Inactive ingredients benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate"],"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 (1-800-222-1222) right away."],"openfda":{},"other_safety_information":["Other information • store at room temperature between 2° and 30°C (36° to 86°F) • see end flaps of carton and tube for lot number and expiration date • Tamper-evident: Safety sealed: the tube opening should be sealed. If seal has been punctured or is not visible, do not use the product."],"package_label_principal_display_panel":["Principal Display Panel Actavis Relabeled by: Preferred Pharmaceuticals Inc. NDC 68788-7682-04 Compare to the active ingredient in Gyne-Lotrimin ® Vaginal Cream* Clotrimazole Vaginal Cream, USP 1% Vaginal Antifungal Cures Most Vaginal Yeast Infections 1 Reusable Applicator (7-Day Therapy) 7-Day Treatment One 45 g (1.5 OZ) Tube of Vaginal Cream (1%) and 1 Reusable Applicator (7-Day Therapy) Educational Pamphlet Enclosed Clotrimazole 7 Vaginal Cream"],"pregnancy_or_breast_feeding":["If pregnant or breast-feeding, ask a health professional before use."],"purpose":["Purpose Vaginal antifungal","Purpose Vaginal antifungal"],"questions":["Questions? 1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday."],"set_id":"37b02587-1582-49f2-88b9-5a57f3e3a242","spl_product_data_elements":["Clotrimazole Clotrimazole CLOTRIMAZOLE CLOTRIMAZOLE BENZYL ALCOHOL CETOSTEARYL ALCOHOL CETYL ESTERS WAX OCTYLDODECANOL POLYSORBATE 60 WATER SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE SORBITAN MONOSTEARATE"],"spl_unclassified_section":["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 a foul-smelling vaginal discharge"],"version":"4","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 a 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 (1-800-222-1222) 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 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"]}