SULFACETAMIDE SODIUM, SULFUR

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)

Brand name: SULFACETAMIDE SODIUM, SULFUR
Generic name: SULFACETAMIDE SODIUM, SULFUR
Manufacturer: Cintex Services, LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 0fa2c52d-5d4a-4b83-e063-6394a90a5406
SPL ID: 0fa2c52d-5d4b-4b83-e063-6394a90a5406
Version: 1
Effective date: 2024-01-23
Source export date: 2026-10-27
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/2026-10-27/2c7d3f7bcea1543046130e07dcbaf7eea5fb0ce23f7faa6458d1c6d80c3fa0c3/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 19:43:56

Harmonized routes table
Harmonized routes
TOPICAL

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 · 13 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		SULFACETAMIDE SODIUM, SULFUR	openfda.brand_name
generic name		SULFACETAMIDE SODIUM, SULFUR	openfda.generic_name
manufacturer name		Cintex Services, LLC	openfda.manufacturer_name
ndc	package	24470-934-02	openfda.package_ndc
ndc	package	24470-934-01	openfda.package_ndc
ndc	product	24470-934	openfda.product_ndc
ndc11	package	24470093401	derived:openfda.package_ndc
ndc11	package	24470093402	derived:openfda.package_ndc
rxcui		1005856	openfda.rxcui
spl id		0fa2c52d-5d4b-4b83-e063-6394a90a5406	id
spl set id		0fa2c52d-5d4a-4b83-e063-6394a90a5406	set_id
unii		4NRT660KJQ	openfda.unii
unii		70FD1KFU70	openfda.unii

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 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 ).

Reported adverse events (FAERS/openFDA)#

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