warnings
WARNINGS NOT FOR INJECTION - FOR TOPICAL OPHTHALMIC USE ONLY. Prolonged use of a topical ocular anesthetic is not recommended. It may produce permanent corneal opacification with accompanying visual loss.
Proparacaine Hydrochloride
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
- Proparacaine Hydrochloride
- Generic name
- PROPARACAINE HYDROCHLORIDE
- Manufacturer
- REMEDYREPACK INC.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 55ed1359-d95c-4c2b-ad5a-cc8e023c4331
- SPL ID
- 4f067d6e-665e-c24f-e063-6294a90ab03e
- Version
- 7
- Effective date
- 2026-04-09
- 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 05:20:15
| 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 | ANDA | 080027 | derived:openfda.application_number |
| application number | ANDA080027 | openfda.application_number | |
| brand name | Proparacaine Hydrochloride | openfda.brand_name | |
| generic name | PROPARACAINE HYDROCHLORIDE | openfda.generic_name | |
| manufacturer name | REMEDYREPACK INC. | openfda.manufacturer_name | |
| ndc | package | 70518-3408-0 | openfda.package_ndc |
| ndc | product | 70518-3408 | openfda.product_ndc |
| ndc11 | package | 70518340800 | derived:openfda.package_ndc |
| rxcui | 1191013 | openfda.rxcui | |
| spl id | 4f067d6e-665e-c24f-e063-6294a90ab03e | id | |
| spl set id | 55ed1359-d95c-4c2b-ad5a-cc8e023c4331 | set_id | |
| unii | U96OL57GOY | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Occasional temporary stinging, burning and conjunctival redness may occur with the use of proparacaine. A rare, severe, immediate-type, apparently hyperallergic corneal reaction characterized by acute, intense and diffuse epithelial keratitis, a gray, ground glass appearance, sloughing of large areas of necrotic epithelium, corneal filaments and, sometimes, iritis with descemetitis has been reported. Allergic contact dermatitis from proparacaine with drying and fissuring of the fingertips has also been reported.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.