FDA.reportPublic FDA data

PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEED CREAM

Manufacturer
Compass Health Brands Corp.
Effective date
2025-04-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:01:54

Label at a glance#

ProductPICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEED
Active ingredientLIDOCAINE, MENTHOL
Label structure8 sections

Dosage and administration

Adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 12 years of age:  ask a doctor.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Menthol 1%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Use

INDICATIONS & USAGE SECTION

  • For the temporary relief of pain

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes
  • Do notuse in large quantities, particularly over raw or blistered areas
  • Do notapply to wounds or damaged skin
  • Do notbandage tightly

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • Condition worsens or symptoms persist for more than 7 days
  • Symptoms clear up and occur again within a few days

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 12 years of age and older:apply to affected area not more than 3 to 4 times daily.

Children under 12 years of age: ask a doctor.

Other Information

SPL UNCLASSIFIED SECTION

  • Store at 15° to 30°C (59° to 86°F)

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Arnica Montana, Carbomer, Cholesterol, Cucumis Sativus (Cucumber) Extract, Fragrance, Glycerin, Hydrogenated Ethylhexyl Olivate, Hydrogenated Olive Oil Unsaponifiables, Leuconostoc/Radish Root Ferment Filtrate, Phenoxyethanol, Polysorbate 80, Propylene Glycol, Tocopheryl Acetate, Water.

Questions?

OTC - QUESTIONS SECTION

Call 800.376.7263

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
250912lidocaine 4 % / menthol 1 % Topical CreamPSN2
250912lidocaine 40 MG/ML / menthol 10 MG/ML Topical CreamSCD2
250912lidocaine 4 % / menthol 1 % 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
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
71323-200-00PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEED113 g in 1 TUBECREAM1132

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71323-20071323-200-00

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
ALOE VERA LEAF JUICERUE8E6T4NBIACT
ARNICA MONTANA WHOLEO80TY208ZWIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CHOLESTEROL97C5T2UQ7JIACT
CUCUMBERYY7C30VXJTIACT
GLYCERINPDC6A3C0OXIACT
HYDROGENATED ETHYLHEXYL OLIVATEJBH5K4WD8LIACT
HYDROGENATED OLIVE OIL UNSAPONIFIABLESB8MIX97W95IACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB
MENTHOLL7T10EIP3AACTIB

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
PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEEDLIDOCAINE, MENTHOLCompass Health Brands Corp.2bd8aae0-2606-c7f2-e063-6294a90a9a202025-04-22WarningsExact identifier
ndc (package): 71323-200-00
ndc (product): 71323-200
ndc11 (package): 71323020000
spl id: 33629b13-1ff4-05cd-e063-6294a90ada76
spl set id: 2bd8aae0-2606-c7f2-e063-6294a90a9a20

Reported adverse events (FAERS/openFDA)#

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