FDA.reportPublic FDA data

FDA label 7e724bec-38d4-41ae-ba9f-c2d29573160a

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
d344f475-1bf2-4aaf-aae3-0cd0be4995d1
SPL ID
7e724bec-38d4-41ae-ba9f-c2d29573160a
Version
5
Effective date
2018-06-13
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:01:03

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

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-999-8403 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ADVERSE REACTIONS Local sensitivity reactions such as increased discomfort or a burning sensation have occasionally been reported following the use of topical sulfonamides. With the use of AVC Cream, sensitivity reactions (only local) were reported for 0.2% of the investigational patients. Treatment should be discontinued if either local or systemic manifestations of sulfonamide toxicity or sensitivity occur.

Reported adverse events (FAERS/openFDA)#

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