warnings and cautions
5.4 Risk of Contamination Do not touch the dropper tip to any surface as this may contaminate the gel.
IHEEZO
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
- IHEEZO
- Generic name
- CHLOROPROCAINE HYDROCHLORIDE OPHTHALMIC GEL
- Manufacturer
- Harrow Eye, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- ea3b2d2c-8b33-d199-e053-2995a90a699c
- SPL ID
- 4dc9b9f7-e722-51ce-e063-6394a90a5219
- Version
- 4
- Effective date
- 2026-03-24
- Source export date
- 2026-10-12
- 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/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:45:56
| 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 | 216227 | derived:openfda.application_number |
| application number | NDA216227 | openfda.application_number | |
| brand name | IHEEZO | openfda.brand_name | |
| generic name | CHLOROPROCAINE HYDROCHLORIDE OPHTHALMIC GEL | openfda.generic_name | |
| manufacturer name | Harrow Eye, LLC | openfda.manufacturer_name | |
| ndc | package | 82667-300-01 | openfda.package_ndc |
| ndc | package | 82667-300-05 | openfda.package_ndc |
| ndc | package | 82667-300-00 | openfda.package_ndc |
| ndc | product | 82667-300 | openfda.product_ndc |
| ndc11 | package | 82667030000 | derived:openfda.package_ndc |
| ndc11 | package | 82667030005 | derived:openfda.package_ndc |
| ndc11 | package | 82667030001 | derived:openfda.package_ndc |
| rxcui | 2613956 | openfda.rxcui | |
| rxcui | 2613961 | openfda.rxcui | |
| spl id | 4dc9b9f7-e722-51ce-e063-6394a90a5219 | id | |
| spl set id | ea3b2d2c-8b33-d199-e053-2995a90a699c | set_id | |
| unii | LT7Z1YW11H | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings and cautions
5.5 For Administration by Healthcare Provider IHEEZO TM is indicated for administration under the direct supervision of a healthcare provider. IHEEZO TM is not intended for patient self-administration.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
6 ADVERSE REACTIONS Most common adverse reaction is mydriasis (approximately 25%) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Harrow at 844.446.6979 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect 201 patients undergoing various surgical ocular procedures in two placebo-controlled trials (Study 1 and Study 2). Patients in Study 1 were randomized to receive a single instillation of 3 drops of IHEEZO TM or placebo. Patients in Study 2 were randomized to receive a single or multiple instillations of 1, 3 or 3+3 drops of IHEEZO TM or placebo. The most common adverse reactions in these studies, (incidence greater than or equal to 5%) following IHEEZO TM administration were mydriasis, conjunctival hyperemia and eye irritation. Adverse Reactions Reported in Controlled Trials Table 1. Adverse Reactions in 5% or more of IHEEZO TM Treated Patients in Studies 1 and 2 IHEEZO TM Placebo Preferred Term N=151 n (%) N=50 n (%) Mydriasis 39 (26%) 1 (2%) Conjunctival hyperemia 16 (11%) 6 (12%) Eye irritation 9 (6%) 2 (4%)
adverse reactions
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described below reflect 201 patients undergoing various surgical ocular procedures in two placebo-controlled trials (Study 1 and Study 2). Patients in Study 1 were randomized to receive a single instillation of 3 drops of IHEEZO TM or placebo. Patients in Study 2 were randomized to receive a single or multiple instillations of 1, 3 or 3+3 drops of IHEEZO TM or placebo. The most common adverse reactions in these studies, (incidence greater than or equal to 5%) following IHEEZO TM administration were mydriasis, conjunctival hyperemia and eye irritation. Adverse Reactions Reported in Controlled Trials Table 1. Adverse Reactions in 5% or more of IHEEZO TM Treated Patients in Studies 1 and 2 IHEEZO TM Placebo Preferred Term N=151 n (%) N=50 n (%) Mydriasis 39 (26%) 1 (2%) Conjunctival hyperemia 16 (11%) 6 (12%) Eye irritation 9 (6%) 2 (4%)
adverse reactions table
<table border="0" width="100%"><tbody><tr><td/><td><content styleCode="bold">IHEEZO <sup>TM</sup></content></td><td><content styleCode="bold">Placebo</content></td></tr><tr><td><content styleCode="bold">Preferred Term</content></td><td><paragraph><content styleCode="bold">N=151</content></paragraph><paragraph><content styleCode="bold">n (%)</content></paragraph></td><td><paragraph><content styleCode="bold">N=50</content></paragraph><paragraph><content styleCode="bold">n (%)</content></paragraph></td></tr><tr><td>Mydriasis</td><td>39 (26%)</td><td><paragraph>1 (2%)</paragraph></td></tr><tr><td>Conjunctival hyperemia</td><td>16 (11%)</td><td>6 (12%)</td></tr><tr><td>Eye irritation</td><td>9 (6%)</td><td>2 (4%)</td></tr></tbody></table>
adverse reactions table
<table border="0" width="100%"><tbody><tr><td/><td><content styleCode="bold">IHEEZO <sup>TM</sup></content></td><td><content styleCode="bold">Placebo</content></td></tr><tr><td><content styleCode="bold">Preferred Term</content></td><td><paragraph><content styleCode="bold">N=151</content></paragraph><paragraph><content styleCode="bold">n (%)</content></paragraph></td><td><paragraph><content styleCode="bold">N=50</content></paragraph><paragraph><content styleCode="bold">n (%)</content></paragraph></td></tr><tr><td>Mydriasis</td><td>39 (26%)</td><td><paragraph>1 (2%)</paragraph></td></tr><tr><td>Conjunctival hyperemia</td><td>16 (11%)</td><td>6 (12%)</td></tr><tr><td>Eye irritation</td><td>9 (6%)</td><td>2 (4%)</td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.