Dr. Rainer s Vaginal Cream

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
Dr. Rainer s Vaginal Cream
Generic name
MICONAZOLE NITRATE
Manufacturer
Plexoris Health Care Products, Llc
Product type
HUMAN OTC DRUG
SPL set ID
1f0ee635-c70d-4194-a01d-370ca5c22fcd
SPL ID
d5efdca4-a729-4a3a-b5c6-1b5c49612fcc
Version
3
Effective date
2024-12-11
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 05:44:59
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. Ask a doctor before use if you have vaginal itching and discomfort for the first time • Abdominal, back, shoulder pain, fever, chills, nausea, vomiting, foul smelling discharge • If you are pregnant or have diabetes • Been exposed to the Human Immunodeficiency Virus (HIV) that causes AIDS Ask a doctor if you are taking 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 • Mild vaginal irritation may occur • Condoms and diaphragms may become damaged and fail to prevent pregnancy or sexually transmitted diseases • If you do not get complete relief consult your doctor Stop use and ask your doctor if symptoms do not get better in 7 days • you get a rash, hives, abdominal pain, fever, chills, nausea, vomiting, or foul smelling discharge • If pregnant or breast feeding ask a doctor before using Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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