Lidocaine 4 Percent Topical Cream

Manufacturer
Marlex Pharmaceuticals Inc
Effective date
2025-11-14
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:16:06

Label at a glance#

ProductLidocaine
Active ingredientLIDOCAINE
Label structure10 sections

Dosage and administration

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily Children under 2 years of age: Consult a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

LIDOCAINE 4%- lidocaine cream

MarlexPharmaceuticals, 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% Topical

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Pain & Itch Relief

Use

INDICATIONS & USAGE SECTION

for the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations

Warnings

WARNINGS SECTION

For external use only. Avoid contact with eyes. Not for prolonged use.

Donotusein large quantities, particularly over raw surfaces or blistered areas.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occurs again within a few days
  • rash or irritation develops, persists, or increases

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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

Children under 2 years of age:Consult a doctor

Other information

SAFE HANDLING WARNING SECTION

  • May be applied under occlusive dressing
  • store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) 

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzyl alcohol, carbomer, hydrogenated lecithin, polysorbate 80, propylene glycol, purified water, trolamine and vitamin E acetate

PRINCIPAL DISPLAY PANEL- 15gTubeCarton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lidocaine 4% Topical Anesthetic Cream

Pain & Itch Relief Cream NET WT. 0.5 oz.(15g)

672-96672-96

PRINCIPAL DISPLAY PANEL-30gTube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lidocaine 4% Topical Anesthetic Cream

Pain & Itch Relief Cream NET WT. (30g)

672-99672-99

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1421893lidocaine 4 % Topical CreamPSN7
1421893lidocaine 40 MG/ML Topical CreamSCD7
1421893lidocaine 4 % Topical CreamSY7

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-672-96Lidocaine1 in 1 CARTONCREAM17
10135-672-96Lidocaine15 g in 1 TUBECREAM157
10135-672-99Lidocaine30 g in 1 TUBECREAM307
10135-672-99Lidocaine1 in 1 CARTONCREAM17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-672-96GM - Gram10135-6726ac4621f-45be-4467-b56b-cbe027135c2512019-01-24
10135-672-99GM - Gram10135-6726d200e7a-361c-40bb-b4ff-918da3997e3f12019-01-24

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10135-67210135-672-96, 10135-672-99

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
LidocaineLIDOCAINEMarlex Pharmaceuticals Inc4de2bc60-dc4a-4417-984f-eabab0e926a62025-11-14WarningsExact identifier
ndc (package): 10135-672-96
ndc (package): 10135-672-99
ndc (product): 10135-672
ndc11 (package): 10135067296
ndc11 (package): 10135067299
spl id: 4391728b-dfe1-3ffb-e063-6394a90a240e
spl set id: 4de2bc60-dc4a-4417-984f-eabab0e926a6

Reported adverse events (FAERS/openFDA)#

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