warnings
WARNINGS NOT FOR INJECTION INTO THE EYE Gentamicin sulfate ophthalmic solution is not for injection. It should never be injected subconjunctivally, nor should it be directly introduced into the anterior chamber of the eye.
Gentamicin Sulfate
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
- Brand name
- Gentamicin Sulfate
- Generic name
- GENTAMICIN SULFATE
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 0bef2a01-69d0-cf50-e063-6294a90a4c52
- SPL ID
- 2d3fc60b-5a42-6abc-e063-6394a90af2a0
- Version
- 2
- Effective date
- 2025-02-03
- 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 06:16:05
| Harmonized routes |
|---|
| OPHTHALMIC |
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 |
|---|---|---|---|
| application applno | ANDA | 064048 | derived:openfda.application_number |
| application number | ANDA064048 | openfda.application_number | |
| brand name | Gentamicin Sulfate | openfda.brand_name | |
| generic name | GENTAMICIN SULFATE | openfda.generic_name | |
| manufacturer name | NuCare Pharmaceuticals,Inc. | openfda.manufacturer_name | |
| ndc | package | 68071-3554-5 | openfda.package_ndc |
| ndc | product | 68071-3554 | openfda.product_ndc |
| ndc11 | package | 68071355405 | derived:openfda.package_ndc |
| rxcui | 310467 | openfda.rxcui | |
| spl id | 2d3fc60b-5a42-6abc-e063-6394a90af2a0 | id | |
| spl set id | 0bef2a01-69d0-cf50-e063-6294a90a4c52 | set_id | |
| unii | 8X7386QRLV | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Bacterial and fungal corneal ulcers have developed during treatment with gentamicin ophthalmic preparations. The most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, non-specific conjunctivitis, conjunctival epithelial defects and conjunctival hyperemia. Other adverse reactions which have occurred rarely are allergic reactions, thrombocytopenic purpura and hallucinations. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.