warnings and cautions
WARNINGS: For external use only. Not for ophthalmic use.
Lidotral 5% Gel
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
- Lidotral 5% Gel
- Generic name
- LIDOCAINE HCL
- Manufacturer
- Puretek Corporation
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 1e183af7-73d7-ff32-e063-6294a90a305b
- SPL ID
- 1e183af7-73d7-ff32-e063-6294a90a305b
- Version
- 1
- Effective date
- 2024-07-25
- Source export date
- 2026-10-27
- 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/2026-10-27/be847f9aea8d80a2cb7e9771acd1143be084664192ecf8f5be8ac1024116f4f0/drug-label-0007-of-0014.json.zip
- Source manifest SHA-256
- 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
- Import run
- 20261027T193451Z
- Imported at
- 2026-10-27 20:12:47
| Harmonized routes |
|---|
| TOPICAL |
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 |
|---|---|---|---|
| brand name | Lidotral 5% Gel | openfda.brand_name | |
| generic name | LIDOCAINE HCL | openfda.generic_name | |
| manufacturer name | Puretek Corporation | openfda.manufacturer_name | |
| ndc | package | 59088-204-07 | openfda.package_ndc |
| ndc | product | 59088-204 | openfda.product_ndc |
| ndc11 | package | 59088020407 | derived:openfda.package_ndc |
| rxcui | 1010057 | openfda.rxcui | |
| spl id | 1e183af7-73d7-ff32-e063-6294a90a305b | id | |
| spl set id | 1e183af7-73d7-ff32-e063-6294a90a305b | set_id | |
| unii | V13007Z41A | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings and cautions
PRECAUTIONS: If irritation or sensitivity occurs or infection appears, discontinue use and institute appropriate therapy. Lidotral® 5% Gel should be used with caution in ill, elderly, debilitated patients and children who may be more sensitive to the systemic effects of lidocaine.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS: During or immediately after treatment, the skin at the site of treatment may develop erythema or edema or may be the locus of abnormal sensation.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.