femmesil Ultra Therapy

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
femmesil Ultra Therapy
Generic name
CLOTRIMAZOLE
Manufacturer
Aidance Scientific, Inc.
Product type
HUMAN OTC DRUG
SPL set ID
3d36794a-07d0-860c-e063-6294a90a6e8f
SPL ID
3d36794a-07d1-860c-e063-6294a90a6e8f
Version
1
Effective date
2025-08-25
Source export date
2026-09-28
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:19:12
Harmonized routes table
Harmonized routes
TOPICAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

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.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.