Miconazole 7

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
Miconazole 7
Generic name
MICONAZOLE NITRATE
Manufacturer
Strategic Sourcing Services LLC
Product type
HUMAN OTC DRUG
SPL set ID
89132802-beb1-42f4-8da4-39918fc5c4dd
SPL ID
274e7b2b-9aaa-4b8e-8cc0-a88ca1cbecde
Version
14
Effective date
2025-09-09
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 05:46:04
Harmonized routes table
Harmonized routes
VAGINAL

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 Ask a doctor before use if you have vaginal itching and discomfort for the first time vaginal yeast infections often (such as once a month or 3 in 6 months). You may have a more serious condition. You could be pregnant or have a medical condition, such as diabetes or a weakened immune system. lower abdominal, back, or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge been exposed to the human immunodeficiency virus (HIV) that causes AIDS Ask a doctor or pharmacist before use if you are taking a prescription blood thinning medicine, such as warfarin, because bleeding or bruising may occur When using this product do not use tampons, douches, spermicides or other vaginal products do not use condoms or diaphragms. They may be damaged by this product and not prevent pregnancy or sexually transmitted diseases (STDs). do not have vaginal intercourse (sex) mild increase in vaginal burning, itching or irritation may occur Stop use and ask a doctor if side effects occur. symptoms do not get better after 3 days symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or 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.

Reported adverse events (FAERS/openFDA)#

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