FDA.reportPublic FDA data

Lidocaine and Prilocaine Cream

Manufacturer
TriRx Huntsville Pharmaceutical Services
Effective date
2024-06-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:01:16

Label at a glance#

ProductLidocaine and Prilocaine Cream
Active ingredientLIDOCAINE, PRILOCAINE
Label structure30 sections

Label contents#

Full prescribing information#

Description

DESCRIPTION SECTION

DescriptionDescription

Clinical Pharmacology

CLINICAL PHARMACOLOGY SECTION

Clinical PharmacologyClinical Pharmacology

Pharmacokinetics 1

PHARMACOKINETICS SECTION

Pharmacokinetics 1Pharmacokinetics 1

Pharmacokinetics 2

PHARMACOKINETICS SECTION

Pharmacokinetics 2Pharmacokinetics 2

Clinical Studies

CLINICAL STUDIES SECTION

Clinical StudiesClinical Studies

Individualization of Dose 1

DOSAGE & ADMINISTRATION SECTION

Individualization of Dose 1Individualization of Dose 1

Individualization of Dose 2

DOSAGE & ADMINISTRATION SECTION

Individualization of Dose 2Individualization of Dose 2

Indications and Usage

INDICATIONS & USAGE SECTION

Indications and UsageIndications and Usage

Contraindications

CONTRAINDICATIONS SECTION

ContraindicationsContraindications

Warnings

WARNINGS SECTION

WarningsWarnings

Precautions

PRECAUTIONS SECTION

PrecautionsPrecautions

Information for Patients

INFORMATION FOR PATIENTS SECTION

Information for PatientsInformation for Patients

Drug Interactions

DRUG INTERACTIONS SECTION

Drug InteractionsDrug Interactions

Use in Pregnancy

PREGNANCY SECTION

Use in PregnancyUse in Pregnancy

Labor and Delivery

LABOR & DELIVERY SECTION

Labor and DeliveryLabor and Delivery

Nursing Mothers

NURSING MOTHERS SECTION

Nursing MothersNursing Mothers

Pediatric Use 1

PEDIATRIC USE SECTION

Pediatric Use 1Pediatric Use 1

Pediatric Use 2

PEDIATRIC USE SECTION

Pediatric Use 2Pediatric Use 2

Geriatric Use

GERIATRIC USE SECTION

Geriatric UseGeriatric Use

Adverse Reactions

ADVERSE REACTIONS SECTION

Adverse ReactionsAdverse Reactions

Overdosage

OVERDOSAGE SECTION

OverdosageOverdosage

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Dosage and AdministrationDosage and Administration

Pediatric Patients-Intact Skin

PEDIATRIC USE SECTION

Pediatric Patients Intact SkinPediatric Patients Intact Skin

Instructions for Application

INSTRUCTIONS FOR USE SECTION

Instructions for ApplicationInstructions for Application

How Supplied

HOW SUPPLIED SECTION

How SuppliedHow Supplied

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

CarcinogenesisCarcinogenesis

Tube 5g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube 5gTube 5g

Tube 30g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube 30gTube 30g

Carton 5g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton 5gCarton 5g

Carton 30g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton 30gCarton 30g

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80432-05380432-053-65, 80432-053-71

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
SODIUM HYDROXIDE55X04QC32IIACT
PRILOCAINE046O35D44RACTIB
PEG-54 HYDROGENATED CASTOR OIL0WZF1506N9IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)HHT01ZNK31IACT
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
1a013e76-e5e3-56b2-e063-6394a90a5f2219fb6823-fcd8-7c08-e063-6294a90aa62e2024-06-03Warnings, Adverse reactionsExact identifier
spl id: 1a013e76-e5e3-56b2-e063-6394a90a5f22
spl set id: 19fb6823-fcd8-7c08-e063-6294a90aa62e

Reported adverse events (FAERS/openFDA)#

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