FDA label 6eaa88ca-0ea3-3d6e-256a-e907bd84fe61
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
- d8f5727d-5447-a535-f526-40930cd7321b
- SPL ID
- 6eaa88ca-0ea3-3d6e-256a-e907bd84fe61
- Version
- 2
- Effective date
- 2013-11-20
- Source export date
- 2026-09-28
- Source partition
- 7
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:50:43
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 | 6eaa88ca-0ea3-3d6e-256a-e907bd84fe61 | id | |
| spl set id | d8f5727d-5447-a535-f526-40930cd7321b | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS SECTION For topical use only - not for injection. Risk-benefit should be considered when the following medical problems exist: keratoconus (homatropine may produce fixed dilated pupil); Down's syndrome, children with brain damage and the elderly (increased susceptibility). In infants and small children, use with extreme caution. Excessive use in pediatric patients or certain individual with a history of susceptibility to belladonna alkaloids may produce systemic symptoms of homatropine poisoning (see overdosage section).
warnings and cautions
WARNINGS AND PRECAUTIONS SECTION To avoid excessive systemic absorption, the lacrimal sac should be compressed by digital pressure for two to three minutes after installation. To avoid inducing angle closure glaucoma, an estimation of the depth of the angle of the anterior chamber should be made. Excessive topical use of this drug can potentially lead to a confusion state characterized by delirium, agitation, and rarely coma. This state is more apt to occur in the pediatric and geriatric age groups. The specific anti-dote for this systemic anticholinergic syndrome is inject able physostigmine salicylate.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS SECTION Transient symptoms of stinging and burning may occur. Prolonged use may produce local irritation characterized by follicular conjunctivitis, vascular congestion, edema, exudates, and an eczematoid dermatitis. Thirst dryness of mouth, eye irritation not present before therapy, or increased sensitivity of eyes to light may occur. To report SUSPECTED ADVERSE REACTIONS, contact Altaire Pharmaceuticals, Inc. at (631)-722-5988.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.