FDA label 04c6beb6-925d-9c08-e063-6394a90a2ad7
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
- SPL set ID
- 817a486f-7668-42fa-8f7c-d67ffc647da5
- SPL ID
- 04c6beb6-925d-9c08-e063-6394a90a2ad7
- Version
- 6
- Effective date
- 2023-09-07
- Source export date
- 2026-11-06
- Source partition
- 1
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-11-06/d05434af5edc4383b7c7894a8f2d94df21171d17714450933cecdfc35cedfa3d/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 06:45:16
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 04c6beb6-925d-9c08-e063-6394a90a2ad7 | id | |
| spl set id | 817a486f-7668-42fa-8f7c-d67ffc647da5 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS: Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals. Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically. Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported. In one of these cases, there was a fatal outcome. KEEP OUT OF THE REACH OF CHILDREN.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS: Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon. The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported (see WARNINGS).
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.