{
"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": [
"Clotrimazole Clotrimazole BENZYL ALCOHOL CETOSTEARYL ALCOHOL CETYL ESTERS WAX OCTYLDODECANOL POLYSORBATE 60 WATER SORBITAN MONOSTEARATE CLOTRIMAZOLE CLOTRIMAZOLE"
],
"spl_unclassified_section": [
"Drug Facts",
"Distributed by: Wellspring Meds Airmont, NY 10952 Made in Canada"
],
"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": [
"
"
],
"indications_and_usage": [
"Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection"
],
"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 right away."
],
"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 a 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."
],
"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: vaginal cream: insert one applicatorful of cream into the vagina at bedtime for 7 days in a row. Wash applicator after each 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. Use 2 times daily for up to 7 days as needed. children under 12 years of age: ask a doctor"
],
"storage_and_handling": [
"Other information To open: unscrew cap, use pointed end on cap to puncture seal do not use if carton is opened safety sealed: the tube opening should be sealed. If the seal has been punctured or is not visible, do not use the product. store between 20° to 25°C (68° to 77°F) see flap of carton or crimp of tube for lot number and expiration date"
],
"inactive_ingredient": [
"Inactive ingredients 2-octyldodecanol, benzyl alcohol, cetostearyl alcohol, cetyl esters wax, polysorbate 60, purified water, sorbitan monostearate"
],
"questions": [
"Questions or comments? call 866-933-6337"
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - 21 g Carton Cures Most Vaginal Yeast Infections 3 Day Treatment 3 Day Vaginal Cream Clotrimazole Vaginal Cream USP (2%) Vaginal Antifungal Educational Brochure Enclosed label tube",
"21 g Carton Label carton"
],
"set_id": "53472e4c-868f-18f5-e063-6394a90abce7",
"id": "53472e56-6294-f22e-e063-6294a90a833c",
"effective_time": "20260901",
"version": "1",
"openfda": {
"application_number": [
"ANDA072641"
],
"brand_name": [
"Clotrimazole"
],
"generic_name": [
"CLOTRIMAZOLE"
],
"manufacturer_name": [
"YYBA CORP"
],
"product_ndc": [
"73581-450"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"VAGINAL"
],
"substance_name": [
"CLOTRIMAZOLE"
],
"rxcui": [
"309368"
],
"spl_id": [
"53472e56-6294-f22e-e063-6294a90a833c"
],
"spl_set_id": [
"53472e4c-868f-18f5-e063-6394a90abce7"
],
"package_ndc": [
"73581-450-01"
],
"is_original_packager": [
true
],
"nui": [
"N0000175487",
"M0002083"
],
"pharm_class_epc": [
"Azole Antifungal [EPC]"
],
"pharm_class_cs": [
"Azoles [CS]"
],
"unii": [
"G07GZ97H65"
]
}
}
]
}