{"active_ingredient":["Active ingredients Purpose Clotrimazole USP, 1% (50 mg in each applicatorful) Vaginal antifungal Clotrimazole USP, 1% (external cream) Vaginal antifungal"],"active_ingredient_table":["
Active ingredients
Purpose
Clotrimazole USP, 1% (50 mg in each applicatorful)
Vaginal antifungal
Clotrimazole USP, 1% (external cream)
Vaginal antifungal
"],"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":"20260331","id":"2acd4dac-129a-47f0-8065-2c831cbf278e","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":{"application_number":["ANDA074165"],"brand_name":["Clotrimazole"],"generic_name":["CLOTRIMAZOLE"],"manufacturer_name":["Preferred Pharmaceuticals Inc."],"nui":["N0000175487","M0002083"],"original_packager_product_ndc":["61269-220"],"package_ndc":["68788-8330-4"],"pharm_class_cs":["Azoles [CS]"],"pharm_class_epc":["Azole Antifungal [EPC]"],"product_ndc":["68788-8330"],"product_type":["HUMAN OTC DRUG"],"route":["VAGINAL"],"rxcui":["309368"],"spl_id":["2acd4dac-129a-47f0-8065-2c831cbf278e"],"spl_set_id":["80d67df3-843d-47bb-85a2-d2f26a824336"],"substance_name":["CLOTRIMAZOLE"],"unii":["G07GZ97H65"]},"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 45 g Tube Carton NDC 68788-8330-4 Clotrimazole Vaginal Cream, USP 1% Vaginal Antifungal (with 1 Reusable Applicator) Cures most vaginal yeast infections 7-day therapy / 7-day treatment Educational pamphlet enclosed Net wt. 1.59 oz (45 g) tube 7 day vaginal cream with 1 reusable applicator H 2 pharma Relabeled By: Preferred Pharmaceuticals Inc. Clotrimazole 7 Vaginal Cream"],"purpose":["Active ingredients Purpose Clotrimazole USP, 1% (50 mg in each applicatorful) Vaginal antifungal Clotrimazole USP, 1% (external cream) Vaginal antifungal"],"purpose_table":["
Active ingredients
Purpose
Clotrimazole USP, 1% (50 mg in each applicatorful)
Vaginal antifungal
Clotrimazole USP, 1% (external cream)
Vaginal antifungal
"],"questions":["Questions? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST"],"set_id":"80d67df3-843d-47bb-85a2-d2f26a824336","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","Distributed by: H2-Pharma, LLC Montgomery, AL 36117 www.h2-pharma.com Relabeled By: Preferred Pharmaceuticals Inc."],"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"],"storage_and_handling":["Other information • to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use • do not use if foil seal on tube opening is broken or missing • do not purchase if carton is open • store at room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F) • before using any medication, read all label directions. Keep carton, it contains important information."],"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 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"]}