CILOXAN
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
- CILOXAN
- Generic name
- CIPROFLOXACIN HYDROCHLORIDE
- Manufacturer
- Sandoz Inc
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 09ca5374-2a16-4a95-91b3-70591d78254e
- SPL ID
- 930a2e4b-dcac-4a27-a073-fd21622c1666
- Version
- 2
- Effective date
- 2024-07-30
- 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 05:18:24
| 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 | NDA | 020369 | derived:openfda.application_number |
| application number | NDA020369 | openfda.application_number | |
| brand name | CILOXAN | openfda.brand_name | |
| generic name | CIPROFLOXACIN HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | Sandoz Inc | openfda.manufacturer_name | |
| ndc | package | 66758-071-38 | openfda.package_ndc |
| ndc | product | 66758-071 | openfda.product_ndc |
| ndc11 | package | 66758007138 | derived:openfda.package_ndc |
| rxcui | 309306 | openfda.rxcui | |
| rxcui | 213307 | openfda.rxcui | |
| spl id | 930a2e4b-dcac-4a27-a073-fd21622c1666 | id | |
| spl set id | 09ca5374-2a16-4a95-91b3-70591d78254e | set_id | |
| unii | 4BA73M5E37 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS: FOR EYE USE ONLY NOT FOR INJECTION INTO THE EYE Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolone therapy. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, tingling, pharyngeal or facial edema, dyspnea, urticaria, and itching. Only a few patients had a history of hypersensitivity reactions. Serious anaphylactic reactions require immediate emergency treatment with epinephrine and other resuscitation measures, including oxygen, intravenous fluids, intravenous antihistamines, corticosteroids, pressor amines, and airway management, as clinically indicated.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS: The following adverse reactions (incidences) were reported in 2% of the patients in clinical studies for CILOXAN ® (ciprofloxacin ophthalmic ointment) 0.3%: discomfort and keratopathy. Other reactions associated with ciprofloxacin therapy occurring in less than 1% of patients included allergic reactions, blurred vision, corneal staining, decreased visual acuity, dry eye, edema, epitheliopathy, eye pain, foreign body sensation, hyperemia, irritation, keratoconjunctivitis, lid erythema, lid margin hyperemia, photophobia, pruritus, and tearing. Systemic adverse reactions related to ciprofloxacin therapy occurred at an incidence below 1% and included dermatitis, nausea and taste perversion.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.