lidocaine hydrochloride gel

Manufacturer
MCURE HEALTH SOLUTIONS INC.
Effective date
2016-05-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:47:53

Label at a glance#

Productlidocaine hydrochloride gel
Active ingredientLIDOCAINE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

MCURE HEALTH SOLUTIONS INC.

20189 CURRIER ROAD, SUITE 200

CITY OF INDUSTRY, CA 91789

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Lidocaine HCI 2.0% Topical Pain Relief

OTC - PURPOSE SECTION

Uses
Temporary pain relief for minor burns

INDICATIONS & USAGE SECTION


Directions
• Adults and children 2 years and older: apply 3 to 4 times daily
• Children under 2: do not use, consult with a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients
Aloe vera, carbomer, germaben II, propylene glycol, purified water, menthol, triethanolamine, vitamin E acetate

WARNINGS SECTION

Warnings
For external use only.
Keep out of reach of childre.
Do not use
• near eyes, if this happens, rinse thoroughly with water
• in large quantities, particularly over raw or blistered areas. Stop use, ask a doctor
• if condition worsens or lasts more than 7 days or clears up and returns. If ingested, contact a poison control center directly

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BURN GELBURN GEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52486-008-022024-11-27C16284748780-19d75b9d1-2409-f424-e053-dadaa90a57ce79bcc02d-838e-2497-e053-2991aa0a9fce
52486-008-022020-01-31C16284748780-19d75b9d1-2409-f424-e053-dadaa90a57ce79bcc02d-838e-2497-e053-2991aa0a9fce

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52486-00852486-008-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
27eeb726-1376-e979-e063-6394a90af30879bcc02d-838e-2497-e053-2991aa0a9fce2024-11-27WarningsExact identifier
spl set id: 79bcc02d-838e-2497-e053-2991aa0a9fce

Reported adverse events (FAERS/openFDA)#

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