FDA.reportPublic FDA data

Carpal Comfort

Manufacturer
Comfort Lab, LP
Effective date
2023-01-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:00

Label at a glance#

ProductCarpal Comfort
Active ingredientBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDE
Label structure13 sections

Storage and handling

Store at room temperature.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzyl Alcohol, Lidocaine HCl

INDICATIONS

INDICATIONS & USAGE SECTION

For temporary relief of pain.

WARNINGS SECTION

  • For external use only
  • Avoid contact with eyes

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, consult physician.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, contact physician prior to use.

OTC - STOP USE SECTION

If symptoms persist more than seven days, discontinue use and consult physician.

ADDITIONAL INFORMATION

STORAGE AND HANDLING SECTION

Store at room temperature.

OTC - PURPOSE SECTION

Topical Anesthetic

INDICATIONS & USAGE SECTION

LIDOCAINE HYDROCHLORIDE

BENZYL ALCOHOL

POLYSORBATE 20

PROPYLENE GLYCOL

BOSWELLIA SERRATA RESIN OIL

ILEX PARAGUARIENSIS LEAF

MAGNESIUM SULFATE, UNSPECIFIED

SPEARMINT OIL

ALCOHOL

TRIETHANOLAMINE SULFATE

XANTHAN GUM

WATER

PHENOXYETHANOL

ARNICA MONTANA FLOWER WATER

DIMETHYL SULFONE

CARBOMER 980

ETHOXYDIGLYCOL BEHENATE

DOSAGE & ADMINISTRATION SECTION

Adults and children two-years of age and older:

Apply to affected area not more than three to four times a day.

Children under two years of age:

Consult a physician

INACTIVE INGREDIENT SECTION

LIDOCAINE HYDROCHLORIDE

BENZYL ALCOHOL

POLYSORBATE 20

PROPYLENE GLYCOL

BOSWELLIA SERRATA RESIN OIL

ILEX PARAGUARIENSIS LEAF

MAGNESIUM SULFATE, UNSPECIFIED

SPEARMINT OIL

ALCOHOL

TRIETHANOLAMINE SULFATE

XANTHAN GUM

WATER

PHENOXYETHANOL

ARNICA MONTANA FLOWER WATER

DIMETHYL SULFONE

CARBOMER 980

ETHOXYDIGLYCOL BEHENATE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottleBoxBox

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZYL ALCOHOL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73214-001-012025-01-30C16284748780-12cef2736-b1fe-d83d-e063-dadaa90ab31fCarpal Comfort

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73214-001-01Carpal Comfort88 mL in 1 TUBE, WITH APPLICATORCREAM882
73214-001-01Carpal Comfort1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73214-001CARPAL COMFORT (BENZYL ALCHOHOL, LIDOCAINE HCI) CREAM [COMFORT LAB, LP]2Legacy NDC, 2 package rows20230111_8d557931-0e2b-29ce-e053-2995a90adf2e.zip

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
73214-00173214-001-01

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
BENZYL ALCOHOLLKG8494WBHACTIB
ETHOXYDIGLYCOL BEHENATEN76ISC4ZZOIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
BOSWELLIA SERRATA RESIN OIL5T1XCE6K8KIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
MAGNESIUM SULFATE, UNSPECIFIEDDE08037SABIACT
SPEARMINT OILC3M81465G5IACT
ALCOHOL3K9958V90MIACT
TRIETHANOLAMINE SULFATEMV1V89M17OIACT
XANTHAN GUMTTV12P4NEEIACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ARNICA MONTANA FLOWER WATERU7L2JP51PRIACT
CARBOMER 9404Q93RCW27EIACT

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
f1e96716-1fa1-51b5-e053-2a95a90a774d8d557931-0e2b-29ce-e053-2995a90adf2e2023-01-10WarningsExact identifier
spl id: f1e96716-1fa1-51b5-e053-2a95a90a774d
spl set id: 8d557931-0e2b-29ce-e053-2995a90adf2e

Reported adverse events (FAERS/openFDA)#

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