FDA label d90b2b1d-b8be-4a67-a958-004d3277ac35
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
- 4db25db3-0494-4b5d-a5e1-c55a12395bb2
- SPL ID
- d90b2b1d-b8be-4a67-a958-004d3277ac35
- Version
- 1
- Effective date
- 2010-06-09
- Source export date
- 2026-09-28
- Source partition
- 12
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:22:44
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 | d90b2b1d-b8be-4a67-a958-004d3277ac35 | id | |
| spl set id | 4db25db3-0494-4b5d-a5e1-c55a12395bb2 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS WARNINGS NOT FOR INJECTION. Do not touch dropper tip to any surface, as this may contaminate the contents. Prolonged use may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection. If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Products containing neomycin sulfate may cause cutaneous sensitization. Employment of corticosteroid medication in the treatment of herpes simplex requires great caution.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS ADVERSE REACTIONS Adverse reactions have occurred with corticosteroid/anti-infective combination drugs which can be attributed to the corticosteroid component, the anti-infective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available. Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitizations. The reactions due to the corticosteroid component are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing. Secondary Infection: The development of secondary infection has occurred after use of combinations containing corticosteroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of corticosteroids. The possibility of fungal invasion must be considered in any persistent corneal ulceration where corticosteroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.