FDA.reportPublic FDA data

Westlake Outdoor Pain Relieving Cream

Manufacturer
WESTLAKE HB PHARMA | Weeks & Leo Co. Inc. | Weeks & Leo Co., Inc
Effective date
2025-07-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:11:20

Label at a glance#

ProductWestlake Outdoor Pain and Itch Relieving
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure14 sections

Storage and handling

store between 20ºC and 25ºC (68ºF and 77ºF)

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Topical analgesic

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

OTC - ASK DOCTOR SECTION

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

OTC - DO NOT USE SECTION

  • in large quantities, particularly over raw surface or blistered areas

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - QUESTIONS SECTION

questions@westlakepharma.com

817-721-6844

WARNINGS SECTION

For external use onlyy

INSTRUCTIONS FOR USE 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

STORAGE AND HANDLING SECTION

store between 20ºC and 25ºC (68ºF and 77ºF)

OTC - WHEN USING SECTION

do not get into eyes

INDICATIONS & USAGE SECTION

  • temporarily relieves pain and itching due to:
    • minor burns
    • sun burns
    • minor cuts
    • scrapes
    • insect bite
    • minor skin irritations

DOSAGE & ADMINISTRATION SECTION

apply to affected area not more than 3 to 4 times daily

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

First Display PanelFirst Display PanelSecond Display PanelSecond Display PanelThird Display PanelThird Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010895lidocaine HCl 4 % Topical CreamPSN1
1010895lidocaine hydrochloride 40 MG/ML Topical CreamSCD1
1010895lidocaine hydrochloride 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
82895-718-50Westlake Outdoor Pain and Itch Relieving49 g in 1 BOTTLE, PLASTICCREAM491

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82895-71882895-718-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
CETETH-20 PHOSPHATE921FTA1500IACT
GLYCERYL STEARATE230OU9XXE4IACT
AMINOMETHYL PROPANOLLU49E6626QIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CAPRYLYL METHICONEQ95M2P1KJLIACT
STEARETH-2153J3F32P58IACT
DIMETHICONE 3502Y53S6ATLUIACT
ALCOHOL3K9958V90MIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
METHYLPARABENA2I8C7HI9TIACT
CETEARYL ALCOHOL2DMT128M1SIACT
C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER4ZK9VP326RIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
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
Westlake Outdoor Pain and Itch RelievingLIDOCAINE 4% PAIN AND ITCH RELIEVINGWESTLAKE HB PHARMA3c563b28-4f4f-9d0c-e063-6294a90adf732025-07-01WarningsExact identifier
ndc (package): 82895-718-50
ndc (product): 82895-718
ndc11 (package): 82895071850
spl id: 3c563b28-4f50-9d0c-e063-6294a90adf73
spl set id: 3c563b28-4f4f-9d0c-e063-6294a90adf73

Reported adverse events (FAERS/openFDA)#

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