ZYLOTROL PAIN RELIEVING

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
ZYLOTROL PAIN RELIEVING
Generic name
LIDOCAINE HCL, MENTHOL
Manufacturer
Asclemed USA, Inc.
Product type
HUMAN OTC DRUG
SPL set ID
1553351c-aee8-4c40-9548-35cce246bda9
SPL ID
254fac91-ba5a-1e5d-e063-6394a90a1199
Version
3
Effective date
2024-10-25
Source export date
2026-09-28
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/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:44:50
Harmonized routes table
Harmonized routes
TOPICAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only. Ask a doctor before use if you have a heart condition. Do not use • if you are allergic to any other type of numbing medicine • in large quantities, particularly over raw surfaces or blistered areas • on infections • on deep puncture wounds • if pregnant or breastfeeding. When using this product • do not use over large skin areas • do not apply heat, bandages or plastic wrap to treated areas • do not use in or near the eyes • wash hands immediately after using. Stop use and ask a doctor if • allergic reaction 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 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.