FDA.reportPublic FDA data

4% Lidocaine Topical Anesthetic Cream

Manufacturer
RUGBY LABORATORIES | Zhejiang Jingwei Pharmaceutical Co., Ltd.
Effective date
2025-06-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:05:56

Label at a glance#

Product4 Lidocaine Topical Anesthetic
Active ingredientLIDOCAINE
Label structure8 sections

Indications and uses

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

Dosage and administration

Adults and children 2 years and older:  Apply externally to the affected area up to 3-4 times daily. Children under 2 years: Consult a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% W/W

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves pain and itching due to:

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

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE 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

Do not use

OTC - DO NOT USE SECTION

over large areas of the body.

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
  • Children under 2 years:Consult a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • Store at USP controlled room temperature 20° to 25°C (68° to 77°F)

Inactive ingredient

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf extract, benzyl alcohol, carbomer homopolymer, cetyl alcohol, cholesterol, di-alpha tocopherol, glycerin, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-639-3803

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package03Outer Package03Inner Package03Inner Package03

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1421893lidocaine 4 % Topical CreamPSN3
1421893lidocaine 40 MG/ML Topical CreamSCD3
1421893lidocaine 4 % Topical CreamSY3

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
0536-1267-204 Lidocaine Topical Anesthetic15 g in 1 BOXCREAM153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1267-20GM - Gram0536-12670339796e-4351-49c1-b69e-7408ac66882a12020-08-06

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-12670536-1267-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CETYL ALCOHOL936JST6JCNIACT
CHOLESTEROL97C5T2UQ7JIACT
.ALPHA.-TOCOPHEROL, DL-7QWA1RIO01IACT
GLYCERINPDC6A3C0OXIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
STEARIC ACID4ELV7Z65APIACT
LIDOCAINE98PI200987ACTIB

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
4 Lidocaine Topical AnestheticLIDOCAINERUGBY LABORATORIES63327e57-f4c8-4ae6-9d28-cef8697bbdcc2025-06-27WarningsExact identifier
ndc (package): 0536-1267-20
ndc (product): 0536-1267
ndc11 (package): 00536126720
spl id: 389094cf-5a17-0699-e063-6294a90a6791
spl set id: 63327e57-f4c8-4ae6-9d28-cef8697bbdcc

Reported adverse events (FAERS/openFDA)#

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