FDA.reportPublic FDA data

Omeza Lidocaine Lavage

Manufacturer
Omeza LLC
Effective date
2022-09-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:50:50

Label at a glance#

ProductOmeza Lidocaine Lavage
Active ingredientLIDOCAINE
Label structure7 sections

Dosage and administration

Adults and children 2 years 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#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 0.8%

Purpose

OTC - PURPOSE SECTION

pain relieving

Use

INDICATIONS & USAGE SECTION

for the temporary relief of pain and itching.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes.

Do not use

OTC - DO NOT USE SECTION

  • in large quantities, particularly over raw surfaces or blistered areas.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur within a few days.

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 to affected area not more than 3 to 4 times daily.
Children under 2 years of age: Consult a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

caprylic/capric triglyceride, caprylic fatty acid, cetyl palmitate, cod liver oil, glyceryl monolaurate, hempseed oil, palm oil

Questions or Comments

OTC - QUESTIONS SECTION

1-888-886-6392

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

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
73033-002-002024-01-30C16284748780-11030e365-25f8-111a-e063-dadaa90a10e2Omeza Lidocaine Lavage

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73033-002-00Omeza Lidocaine Lavage10 in 1 BOXOIL103
73033-002-00Omeza Lidocaine Lavage1 in 1 POUCHOIL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73033-002OMEZA LIDOCAINE LAVAGE (LIDOCAINE) OIL [OMEZA LLC]3Legacy NDC, 2 package rows20220923_4e5cc632-a41b-464c-96d3-441986ab60af.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73033-00273033-002-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETYL PALMITATE5ZA2S6B08XIACT
COD LIVER OILBBL281NWFGIACT
GLYCERYL LAURATEY98611C087IACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
PALM OIL5QUO05548ZIACT
LIDOCAINE98PI200987ACTIB

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
e9417d7a-fae3-ddc4-e053-2a95a90a7da34e5cc632-a41b-464c-96d3-441986ab60af2022-09-22WarningsExact identifier
spl id: e9417d7a-fae3-ddc4-e053-2a95a90a7da3
spl set id: 4e5cc632-a41b-464c-96d3-441986ab60af

Reported adverse events (FAERS/openFDA)#

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