Lidocaine 4%

Manufacturer
Innovida Pharmaeutique Corporation
Effective date
2025-03-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:57:32

Label at a glance#

ProductLidocaine 4%
Active ingredientLIDOCAINE
Label structure8 sections

Indications and uses

For the temporary relief of pain and itching, associated with minor burns,sun burn, minor cuts, scrapes, insect bites, minor skin irritations, rashes due to poison ivy, poison oak, fever blister, cold sores.

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: Do not use, consult a doctor.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching, associated with minor burns,sun burn, minor cuts, scrapes, insect bites, minor skin irritations, rashes due to poison ivy, poison oak, fever blister, cold sores.

Warnings

WARNINGS SECTION

For external Use only

  • Avoid contact with the eyes.
  • Do not use in large quantities, particularly over raw surfaces or blistered areas.

Stop Use and Ask a Doctor if

  • condition worsens or if symptoms persist for more than 7 days 
  • or occur again within a few days.

Keep out of reach of children. 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: Do not use, consult a doctor.

Other information

SPL UNCLASSIFIED SECTION

Store at room temperature, 20 – 25°C (68-77°F).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water),Carbomer, Cetearyl Alcohol, Ethylhexylglycerin, Glycerin, Glyceryl Stearate SE,Helianthus Annuus (Sunflower) Oil, Phenoxyethanol, Polysorabte-20, Polysorbate-60, Simmondsia Chinensis (Jojoba) Oil, Stearic Acid, Triethanolamine.

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1421893lidocaine 4 % Topical CreamPSN1
1421893lidocaine 40 MG/ML Topical CreamSCD1
1421893lidocaine 4 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71800-026-06Lidocaine 4%58.5 g in 1 BOTTLECREAM58.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71800-026LIDOCAINE 4% (LIDOCAINE) CREAM [INNOVIDA PHARMAEUTIQUE CORPORATION]1Current NDC, 1 package rows20250322_eb83a3dd-557e-4334-b806-5fc05e9175a3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71800-026-06GM - Gram71800-026fadb0908-19af-4f11-92c8-8b96e8035ecb12025-06-13

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71800-02671800-026-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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
Lidocaine 4%LIDOCAINEInnovida Pharmaeutique Corporationeb83a3dd-557e-4334-b806-5fc05e9175a32025-03-19WarningsExact identifier
ndc (package): 71800-026-06
ndc (product): 71800-026
ndc11 (package): 71800002606
spl id: 30b82f5d-2c7d-3572-e063-6394a90a3ec3
spl set id: eb83a3dd-557e-4334-b806-5fc05e9175a3

Reported adverse events (FAERS/openFDA)#

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