FDA.reportPublic FDA data

Lidocaine 4 Percent and Menthol 1 Percent Roll-On

Manufacturer
Alexso, Inc
Effective date
2021-02-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:38:14

Label at a glance#

ProductLidocaine 4 Percent and Menthol 1 Percent Roll-On
Active ingredientLIDOCAINE HYDROCHLORIDE, MENTHOL
Label structure9 sections

Indications and uses

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

Dosage and administration

 adults and children 2 years and older  apply externally to the affected area up to 3 to 4  times a day  children under 2 years do not use except under the advice and supervision of a physician

Storage and handling

May be applied under occlusive dressing. Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F).  See USP Controlled Room Temperature.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

LIDOCAINE AND MENTHOL - Lidocaine 4% and Menthol 1% Roll-On
Alexso, Inc 

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Lidocaine 4% and Menthol 1% Roll-On

​Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%
Menthol 1%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic
Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves pain and itching due to:

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

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
  • do not apply to wounds or damaged skin
  • do not bandage

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

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 2 years and older apply externally to the affected area up to 3 to 4  times a day
 children under 2 years do not use except under the advice and supervision of a physician

Other information

STORAGE AND HANDLING SECTION

  • May be applied under occlusive dressing.
  • Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F).  See USP Controlled Room Temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Glycerin, Borneol, Arnica Montana Flower Extract, Polyethylene Glycol (PEG), Frankincense Oil, Boswellia Extract, Methylsulfonylmethane (MSM), Chondroitin Sulfate, Glucosamine Sulfate, Water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lidocaine 4% and Menthol 1% Roll-On

NDC 50488-6541-1

50 mL

Manufactured for:
Alexso, Inc.
Los Angeles, CA 90064

Lidocaine 4% and Menthol 1% Roll-On NDC 50488-6541-1 50 mL Manufactured for: Alexso, Inc. Los Angeles, CA 90064Lidocaine 4% and Menthol 1% Roll-On NDC 50488-6541-1 50 mL Manufactured for: Alexso, Inc. Los Angeles, CA 90064

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
252967lidocaine 4 % / menthol 1 % Topical SolutionPSN2
252967lidocaine 40 MG/ML / menthol 10 MG/ML Topical SolutionSCD2

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50488-6541-12024-01-30C16284748780-11030e365-0f64-111a-e063-dadaa90a10e2Lidocaine and Menthol Roll-On

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50488-6541-1Lidocaine 4 Percent and Menthol 1 Percent Roll-On50 mL in 1 BOTTLE, WITH APPLICATORLIQUID502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50488-6541LIDOCAINE 4 PERCENT AND MENTHOL 1 PERCENT ROLL-ON (LIDOCAINE AND MENTHOL) LIQUID [ALEXSO, INC]2Legacy NDC, 1 package rows20210220_511ee92e-f69c-4d21-aadd-84a06aca00c2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50488-6541-1ML - Milliliter50488-65410349156e-01df-48d5-9183-54997edcd6e612021-05-05

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
50488-654150488-6541-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
MENTHOLL7T10EIP3AACTIB
GLYCERINPDC6A3C0OXIACT
BORNEOLM89NIB437XIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
FRANKINCENSE OIL67ZYA5T02KIACT
BOSWELLIA SACRA WHOLE8O600AZL0WIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
CHONDROITIN SULFATE (BOVINE)6IC1M3OG5ZIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
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
e2dc4651-36ef-4bc9-b427-718e53292dbc511ee92e-f69c-4d21-aadd-84a06aca00c22021-02-23WarningsExact identifier
spl id: e2dc4651-36ef-4bc9-b427-718e53292dbc
spl set id: 511ee92e-f69c-4d21-aadd-84a06aca00c2

Reported adverse events (FAERS/openFDA)#

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