FDA.reportPublic FDA data

Westlake Lidocaine HCL 4% Cream

Manufacturer
Westlake Pharma LLC | Weeks & Leo Company Inc
Effective date
2025-12-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:19:12

Label at a glance#

ProductWestlake Lidocaine
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

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

Dosage and administration

adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily children under 2 years: ask a doctor

Storage and handling

store between 20 °C and 25 °C (68 °F and 77 °F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves pain and itching due to:

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

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use in large quantities, particularly over raw surfaces or blistered areas

OTC - WHEN USING SECTION

When using this product do not get into eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition gets worse
  • symptoms last for more than 7 days
  • symptoms clear up and occur again within a few days

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 2 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

store between 20 °C and 25 °C (68 °F and 77 °F)

INACTIVE INGREDIENT SECTION

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis (aloe vera) leaf juice, aminomethyl propanol,
C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, edetate disodium, ethylhexylglycerin, glyceryl monostearate, methylparaben, purified water, SD alcohol 40, steareth-21

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

76-291-23v3.0 Carton76-291-23v3.0 CartonMaximum Strength

Lidocaine

Pain Relief

Cream

Lidocaine HCl 4% Topical Analgesic

Non Greasy

Compare to aspercreme lidocaine cream

active ingredient

100% Money Back Guarantee

Net wt 1.75 oz (49 g)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010895lidocaine HCl 4 % Topical CreamPSN2
1010895lidocaine hydrochloride 40 MG/ML Topical CreamSCD2
1010895lidocaine hydrochloride 4 % Topical CreamSY2

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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
82895-717-50Westlake Lidocaine1 in 1 CARTONCREAM12
82895-717-50Westlake Lidocaine49 g in 1 BOTTLE, PLASTICCREAM492

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82895-71782895-717-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER4ZK9VP326RIACT
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
DICETYL PHOSPHATE2V6E5WN99NIACT
DIMETHICONE 3502Y53S6ATLUIACT
ALOE VERA LEAFZY81Z83H0XIACT
CETEARYL ALCOHOL2DMT128M1SIACT
METHYLPARABENA2I8C7HI9TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETETH-20 PHOSPHATE921FTA1500IACT
STEARETH-2153J3F32P58IACT
CAPRYLYL METHICONEQ95M2P1KJLIACT
ALCOHOL3K9958V90MIACT

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
Westlake LidocaineLIDOCAINE HCLWestlake Pharma LLC0c586a14-1a2a-9f42-e063-6294a90a16c12025-12-03WarningsExact identifier
ndc (package): 82895-717-50
ndc (product): 82895-717
ndc11 (package): 82895071750
spl id: 45104890-d7b7-5d3d-e063-6394a90ad546
spl set id: 0c586a14-1a2a-9f42-e063-6294a90a16c1

Reported adverse events (FAERS/openFDA)#

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