warnings
WARNINGS Avoid contact with the eyes. In the event of a sensitization or severe local irritation from BACTROBAN CREAM, usage should be discontinued, and appropriate alternative therapy for the infection instituted.
FDA label 76d3c42c-12e8-4135-8ccf-3f3cb2d49de0
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
- 87734c71-a574-465d-b941-f993f9ae8b2b
- SPL ID
- 76d3c42c-12e8-4135-8ccf-3f3cb2d49de0
- Version
- 1
- Effective date
- 2007-02-13
- Source export date
- 2026-09-28
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:21:38
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 | 76d3c42c-12e8-4135-8ccf-3f3cb2d49de0 | id | |
| spl set id | 87734c71-a574-465d-b941-f993f9ae8b2b | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
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adverse reactions
ADVERSE REACTIONS In 2 randomized, double-blind, double-dummy trials, 339 patients were treated with topical BACTROBAN CREAM plus oral placebo. Adverse events thought to be possibly or probably drug-related occurred in 28 (8.3%) patients. The incidence of those events that were reported in at least 1% of patients enrolled in these trials were: Headache (1.7%), rash, and nausea (1.1% each). Other adverse events thought to be possibly or probably drug-related which occurred in less than 1% of patients were: Abdominal pain, burning at application site, cellulitis, dermatitis, dizziness, pruritus, secondary wound infection, and ulcerative stomatitis. In a supportive study in the treatment of secondarily infected eczema, 82 patients were treated with BACTROBAN CREAM. The incidence of adverse events thought to be possibly or probably drug-related was as follows: Nausea (4.9%), headache, and burning at application site (3.6% each), pruritus (2.4%) and 1 report each of abdominal pain, bleeding secondary to eczema, pain secondary to eczema, hives, dry skin, and rash.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.