Lidocaine 4% plus Menthol 1% Topical Anesthetic Pain Cream

Manufacturer
MOHNARK PHARMACEUTICALS INC
Effective date
2025-08-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:10:48

Label at a glance#

ProductLidocaine 4% plus Menthol 1% Topical Anesthetic Pain Cream
Active ingredientLIDOCAINE, MENTHOL
Label structure12 sections

Indications and uses

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

Dosage and administration

• Adults and children 2 years and older: apply externally to the affected area up to 3-4 times a day. • Children under 2 years of age: consult a doctor.

Storage and handling

• Store at USP controlled room temperature 20-25°C (68-77°F).

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%
Menthol 1%

Uses

OTC - PURPOSE SECTION

temporarily relieves pain and itching due to:

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

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 area

Stop use and ask a doctor if

OTC - ASK DOCTOR 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

INSTRUCTIONS FOR USE SECTION

• Adults and children 2 years and
older: apply externally to the
affected area up to 3-4 times a day.
• Children under 2 years of age:
consult a doctor.

Other information

STORAGE AND HANDLING SECTION

• Store at USP controlled room
temperature 20-25°C (68-77°F).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin,
polysorbate 80, propylene glycol, tocopheryl acetate, trolamine,
water.

Usage

INDICATIONS & USAGE SECTION

Lidocaine 4% cream is indicated for use on normal intact skin for temporary relief of pain and itching due to minor cuts, minor scrapes, minor skin irritations, minor burns and insect bites.

Lidocaine 4% cream is not recommended for internal use, in the or near the eyes and in large quantities, particularly over raw surfaces or blistered areas.

Dosage and Administration

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 of age. Consult a doctor.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lidocaine 4% plus Menthol 1%Lidocaine 4% plus Menthol 1%

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
73715-006-01Lidocaine 4% plus Menthol 1% Topical Anesthetic Pain Cream30 g in 1 TUBECREAM301

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73715-00673715-006-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 806OZP39ZG8HIACT
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
3c723fdf-cb6e-53b0-e063-6294a90a13393c723fdf-cb6d-53b0-e063-6294a90a13392025-08-15WarningsExact identifier
spl id: 3c723fdf-cb6e-53b0-e063-6294a90a1339
spl set id: 3c723fdf-cb6d-53b0-e063-6294a90a1339

Reported adverse events (FAERS/openFDA)#

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