FDA.reportPublic FDA data

Lidocaine 4% Topical Anesthetic Cream

Manufacturer
Medcore LLC
Effective date
2026-05-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:56:46

Label at a glance#

ProductLidocaine 4% Cream
Active ingredientLIDOCAINE
Label structure11 sections

Indications and uses

Temporarily relieves pain and itching due to: minor cuts sunburn minor scrapes minor burns insect bites minor skin irritations

Dosage and administration

Adults and children 2 years and older: apply externally to the affected area up to 3 to 4 times a day Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day. children under 2 years ask a doctor

Storage and handling

Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% w/w

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves pain and itching due to:

  • minor cuts
  • sunburn
  • minor scrapes
  • minor burns
  • insect bites
  • minor skin irritations

Warnings

WARNINGS SECTION

For external use only.

When using this product

  • do not use in or near the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas
  • do not use If pregenant or breastfeeding.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years and older:

apply externally to the affected area up to 3 to 4 times a day

Adults and children 12 years and older:

Apply externally to the affected area up to 6 times a day.

children under 2 years ask a doctor

OTHER INFORMATION

STORAGE AND HANDLING SECTION

Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

STEARIC ACID , GLYCERYL-STEARATE, PEG-100 STEARATE , SODIUM POLYACRYLATE , GLUCOSAMINE SULFATE , TROLAMINE , LAURETH, ISOSTEARYL PALMITATE, PROPYLENE GLYCOL , DIMETHYL SULFONE , C13-14 ISOPARAFFIN, PHENOXYETHANOL, POLYACRYLAMIDE, CETOSTEARYL ALCOHOL , CHONDROITIN SULFATE , Pure Water, Peppermint oil

Stop use and ask a doctor if

SPL UNCLASSIFIED SECTION

  • 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

Manufactured For:

SPL UNCLASSIFIED SECTION

Medcore LLC 3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC:82461-419-30

Lidocaine 4%
Topical Anesthetic Cream

Medcore LLC

30 gram

lidocaine 4%
lidocaine 4%
lidocaine 4%
lidocaine 4%

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1421893lidocaine 4 % Topical CreamPSN1
1421893lidocaine 40 MG/ML Topical CreamSCD1
1421893lidocaine 4 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82461-419-30Lidocaine 4% Cream30 g in 1 TUBECREAM301
82461-419-30Lidocaine 4% Cream1 in 1 BOXCREAM11

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82461-41982461-419-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
STEARIC ACID4ELV7Z65APIACT
GLYCERYL 1-STEARATE258491E1RZIACT
PEG-100 MONOSTEARATEYD01N1999RIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
TROLAMINE9O3K93S3TKIACT
LAURETH-7Z95S6G8201IACT
ISOSTEARYL PALMITATE9EHU0R7ER1IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PEPPERMINT OILAV092KU4JHIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHONDROITIN SULFATE (BOVINE)6IC1M3OG5ZIACT
WATER059QF0KO0RIACT

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
Lidocaine 4% CreamLIDOCAINEMedcore LLC111cb421-ba3b-4772-ab60-d31eb41831682026-05-07WarningsExact identifier
ndc (package): 82461-419-30
ndc (product): 82461-419
ndc11 (package): 82461041930
spl id: 145a9966-470b-4ad6-a267-6418fe5fe509
spl set id: 111cb421-ba3b-4772-ab60-d31eb4183168

Reported adverse events (FAERS/openFDA)#

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