FDA label 07080003-b495-447a-bb9d-0efbe866e37a
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
- 94e3b620-f9b2-4c8b-9ee8-8b27207a2cab
- SPL ID
- 07080003-b495-447a-bb9d-0efbe866e37a
- Version
- 3
- Effective date
- 2011-11-09
- Source export date
- 2026-09-28
- Source partition
- 3
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:21:44
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 | 07080003-b495-447a-bb9d-0efbe866e37a | id | |
| spl set id | 94e3b620-f9b2-4c8b-9ee8-8b27207a2cab | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS: NOT FOR INJECTION INTO THE EYE. This product should never be directly introduced into the anterior chamber of the eye or injected subconjunctivally. Topical antibiotics, particularly neomycin sulfate, may cause cutaneous sensitization. A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known. The manifestations of sensitization to topical antibiotics are usually itching, reddening and edema of the conjunctiva and eyelid. A sensitization reaction may manifest simply as a failure to heal. During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. Symptoms usually subside quickly on withdrawing the medication. Applications of products containing these ingredients should be avoided for the patient thereafter. (See PRECAUTIONS , General ).
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS: Adverse reactions have occurred with the anti-infective components of this product. The exact incidence is not known. Reactions occurring most often are allergic reactions including itching, swelling, and conjunctival erythema (see WARNINGS ). More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely. Local irritation on instillation has also been reported.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.