FDA.reportPublic FDA data

BENZOCAINE 20% / LIDOCAINE 10% / TETRACAINE 10%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-05-17
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:48

Label at a glance#

ProductBENZOCAINE 20% / LIDOCAINE 10% / TETRACAINE 10%
Active ingredientTETRACAINE, BENZOCAINE, LIDOCAINE
Label structure4 sections

Label contents#

Full prescribing information#

Directions for use

INSTRUCTIONS FOR USE SECTION

adad

Sincerus Florida, LLC. Adverse reactions

ADVERSE REACTIONS SECTION

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Active, inactive

COMPONENTS

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NDC 72934- 5040-2 BENZOCAINE USP 20% / LIDOCAINE USP 10% / TETRACAINE USP 10%. Ointment 120gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
a26f29b9-6919-4f09-a354-491df8d2b97dProduct name120251021
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
122d1fa8-7b9e-49b4-89ce-b062ffd1d947Product name120181030
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818
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
72934-5009-22021-01-29C16284748780-1ba0f9c33-3b37-a910-e053-dadaa90a0b85BENZOCAINE 20% / LIDOCAINE 10% / TETRACAINE 10%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-5009-2BENZOCAINE 20% / LIDOCAINE 10% / TETRACAINE 10%30 g in 1 BOTTLE, PUMPOINTMENT301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-5009BENZOCAINE 20% / LIDOCAINE 10% / TETRACAINE 10% OINTMENT [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190518_8916cdc8-bd9a-74fa-e053-2a95a90a615a.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72934-500972934-5009-2

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
TETRACAINE0619F35CGVACTIB
BENZOCAINEU3RSY48JW5ACTIB
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
8916cdc8-bd9b-74fa-e053-2a95a90a615a8916cdc8-bd9a-74fa-e053-2a95a90a615a2019-05-17Adverse reactionsExact identifier
spl id: 8916cdc8-bd9b-74fa-e053-2a95a90a615a
spl set id: 8916cdc8-bd9a-74fa-e053-2a95a90a615a

Reported adverse events (FAERS/openFDA)#

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