FDA label 25a5b978-c576-4483-9c64-7f71663196ce

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: e03abb55-9786-43c8-97cf-ba1847f376f8
SPL ID: 25a5b978-c576-4483-9c64-7f71663196ce
Version: 2
Effective date: 2016-07-27
Source export date: 2026-08-08
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-08-08/13477f292fde418ab8b889dedaeed5fd633628cccdf0fe6d78a20f4b857aa1ee/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run: 20260810T161303Z
Imported at: 2026-08-10 17:39:11

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		25a5b978-c576-4483-9c64-7f71663196ce	id
spl set id		e03abb55-9786-43c8-97cf-ba1847f376f8	set_id

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

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#

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

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 ).