FDA label 3bd3a52d-eb00-1c9f-e063-6394a90abbb6

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)

SPL set ID
3bd3a52d-eaff-1c9f-e063-6394a90abbb6
SPL ID
3bd3a52d-eb00-1c9f-e063-6394a90abbb6
Version
1
Effective date
2025-08-08
Source export date
2026-09-28
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:48:16

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 this product if you have a known allergy to any of its ingredients. • Consult your healthcare provider before use if you are pregnant, breastfeeding, or undergoing treatment for a vaginal infection. • Do not use this product if the seal is broken or missing. • In case of accidental ingestion, seek medical assistance or contact a Poison Control Center immediately. When using this product • Administer only as directed. Avoid exceeding the recommended application frequency. • To prevent potential desensitization or tolerance, do not use the product more than once within a 48 - hour period unless otherwise advised by a healthcare professional. • Before using this product with other therapeutic products such as douches, spermicides, or antifungal treatments, seek medical guidance to avoid interactions or diminished therapeutic efficacy. • Mild vaginal sensations, including burning, itching, or irritation, may occur initially. Should these symptoms persist, intensify, or be accompanied by abnormal discharge, bleeding, or systemic symptoms (e.g., fever, chills), discontinue use and consult a healthcare provider promptly. • Do not reuse or share the applicator to minimize the risk of contamination or infection. Dispose of the applicator after a single use. Stop Use and Consult a Healthcare Provider If • Symptoms do not improve after 3 applications or worsen during use. • You experience severe vaginal irritation, abnormal discharge, or unexpected bleeding. • Systemic symptoms such as fever, chills, or abdominal pain occur. • Premenopausal women experience any of the above - mentioned symptoms. If Pregnant or Breastfeeding Consult a healthcare provider before using this product to ensure its safety and suitability during pregnancy or lactation. keep out of reach of children This product is intended for adult use only. In case of accidental ingestion by a child, seek immediate medical attention or contact a Poison Control Center.

Reported adverse events (FAERS/openFDA)#

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