warnings and cautions
WARNINGS: For external use only. Not for ophthalmic use.
Lidocaine 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
- Lidocaine 5% Gel
- Generic name
- LIDOCAINE HCL 5%
- Manufacturer
- Puretek Corporation
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 3f2f0f2b-2759-c010-e063-6394a90a8e5e
- SPL ID
- 3f30281e-eecd-dad9-e063-6394a90a5d0e
- Version
- 1
- Effective date
- 2025-09-19
- Source export date
- 2026-09-28
- 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/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:16:37
| 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 | Lidocaine 5% Gel | openfda.brand_name | |
| generic name | LIDOCAINE HCL 5% | openfda.generic_name | |
| manufacturer name | Puretek Corporation | openfda.manufacturer_name | |
| ndc | package | 59088-247-07 | openfda.package_ndc |
| ndc | product | 59088-247 | openfda.product_ndc |
| ndc11 | package | 59088024707 | derived:openfda.package_ndc |
| rxcui | 1010057 | openfda.rxcui | |
| spl id | 3f30281e-eecd-dad9-e063-6394a90a5d0e | id | |
| spl set id | 3f2f0f2b-2759-c010-e063-6394a90a8e5e | 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. Lidocaine 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.