FDA label 3d00ca32-7ca9-4bc1-9569-edefa6e3b630

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
c4e07c26-245d-3e51-6a47-fccde22334d2
SPL ID
3d00ca32-7ca9-4bc1-9569-edefa6e3b630
Version
4
Effective date
2025-08-25
Source export date
2026-10-12
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:38:12

Adverse reactions cross-check#

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

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS In a controlled clinical trial, safety data from 141 patients who used MetroLotion ® Topical Lotion (n=71), or the lotion vehicle (n=70), twice daily and experienced a local cutaneous adverse event which may or may not have been related to the treatments include: local allergic reaction, MetroLotion ® Topical Lotion 2 (3%), lotion vehicle 0; contact dermatitis, MetroLotion ® Topical Lotion 2 (3%), lotion vehicle 1 (1%); pruritus, MetroLotion ® Topical Lotion 1 (1%), lotion vehicle 0; skin discomfort (burning and stinging), MetroLotion ® Topical Lotion 1 (1%), lotion vehicle 2 (3%); erythema, MetroLotion ® Topical Lotion 4 (6%), lotion vehicle 0; dry skin, MetroLotion ® Topical Lotion 0, lotion vehicle 1 (l%); and worsening of rosacea, MetroLotion ® Topical Lotion 1 (1%), lotion vehicle 7 (10%). The following additional adverse experiences have been reported with the topical use of metronidazole: skin irritation, transient redness, metallic taste, tingling or numbness of extremities, and nausea.

Reported adverse events (FAERS/openFDA)#

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