FDA.reportPublic FDA data

BENZOCAINE 20% / LIDOCAINE 10% / TETRACAINE 10%

Manufacturer
Sincerus Florida, LLC
Effective date
2019-05-22
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:28:55

Key Label Information#

Directions And Dosage

Directions for use

Other Label Information

NDC 72934- 2009-2 BENZOCAINE 20% / LIDOCAINE 10% / TETRACAINE 10% . Cream 30 gm

Label Images#

-2 end
-2 end
2009-2 middle
2009-2 middle
2009-2 front
2009-2 front

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
72934-2009-22021-01-29C16284748780-1ba0f9c33-11d6-a910-e053-dadaa90a0b85BENZOCAINE 20% / LIDOCAINE 10% / TETRACAINE 10%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72934-2009-2BENZOCAINE 20% / LIDOCAINE 10% / TETRACAINE 10%30 g in 1 BOTTLE, PUMPCREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72934-2009BENZOCAINE 20% / LIDOCAINE 10% / TETRACAINE 10% CREAM [SINCERUS FLORIDA, LLC]1Legacy NDC, 1 package rows20190523_897fba62-e2f2-b4df-e053-2995a90aaf60.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72934-200972934-2009-2

Ingredients#

Name, UNII, Kind table
NameUNIIKind
BENZOCAINEU3RSY48JW5ACTIB
LIDOCAINE98PI200987ACTIB
TETRACAINE0619F35CGVACTIB

Complete SPL Sections#

Directions for use

INSTRUCTIONS FOR USE SECTION

Sincerus Florida, LLC. Adverse reactions

ADVERSE REACTIONS SECTION

Active, inactive

COMPONENTS

NDC 72934- 2009-2 BENZOCAINE 20% / LIDOCAINE 10% / TETRACAINE 10% . Cream 30 gm

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Source Document#

Source XML