FDA label 8e3e2cde-dac8-471b-a03d-97c99025aaeb

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
3f875c91-3eaa-4d99-a5e4-27604f5be5be
SPL ID
8e3e2cde-dac8-471b-a03d-97c99025aaeb
Version
2
Effective date
2013-09-30
Source export date
2026-10-12
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:20:57

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

WARNING The safe use of T-STAT (erythromycin) 2.0% Solution during pregnancy or lactation has not been established.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS Adverse conditions reported include dryness, tenderness, pruritis, desquamation, erythema, oiliness, and burning sensation. Irritation of the eyes has also been reported. A case of generalized urticarial reaction, possibly related to the drug, which required the use of systemic steroid therapy has been reported.

Reported adverse events (FAERS/openFDA)#

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