TOPICAINE 5

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 (canonical bytes are SHA-256 checked before publication)

Brand name
TOPICAINE 5
Generic name
LIDOCAINE 5%
Manufacturer
ESBA LABORATORIES INC.
Product type
HUMAN OTC DRUG
SPL set ID
15d33ff7-34ed-253d-e054-00144ff88e88
SPL ID
47e9cb0c-dbdb-3ee0-e063-6394a90a9052
Version
11
Effective date
2026-01-08
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 06:17:11
Harmonized routes table
Harmonized routes
TOPICAL

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only Flammable Keep away from sparks, heat and fire. Cap tube tightly when not in use. When using this product avoid contact with eyes do not use in large quantities, particularly over raw surfaces or blistered areas do not put in rectum do not exceed recommended dosage unless directed by a doctor Stop use and ask a doctor if: allergic reaction occurs rectal bleeding occurs condition worsens or does not improve within 7 days symptoms clear up and return within a few days redness, irritation, swelling, pain or other symptoms begin or increase. Keep out of the reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.