FDA.reportPublic FDA data

TOPICAINE

Manufacturer
ESBA LABORATORIES INC.
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
monthly-update
Hydrated at
2026-06-03 17:52:36

Label at a glance#

ProductTOPICAINE
Active ingredientLIDOCAINE
Label structure10 sections

Indications and uses

For the temporary relief of pain.

Dosage and administration

Apply externally to affected area up to 3 to 4 times a day. Children under 2 years of age consult a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% w/w

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain.

Warnings

WARNINGS SECTION

For external use only

Flammable

Keep away from sparks, heat and fire. Cap tube tightly when not in use.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • you notice any unusual effects

Keep out of the 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

Apply externally to affected area up to 3 to 4 times a day. Children under 2 years of age consult a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Carbomer, Disodium EDTA, Glycerin, Glyceryl Laurate, SD Alcohol 40B, Simmondsia Chinensis (Jojoba) Seed Oil, Water

Questions

OTC - QUESTIONS SECTION

Call toll-free in USA & Canada 800-677-9299 or visit www.topicaine.com

Labelling on tubes and outer cartons

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Labelling printed on tube of Topicaine 4% 10 gram tube:

Printing on the tube of Topicaine 4% 10 gPrinting on the tube of Topicaine 4% 10 g

Outer carton of Topicaine 4% 10 grams:

Box of Topicaine 4% 10 gramsBox of Topicaine 4% 10 grams

Label affixed to Topicaine 4% 30 gram tubes:

Label affixed to tubes of Topicain 4% 30 gramsLabel affixed to tubes of Topicain 4% 30 grams

Outer box of Topicaine 4% 30 grams:

Box for Topicaine 4% 30 gram tubesBox for Topicaine 4% 30 gram tubes

Label affixed to tubes of Topicaine 4% 113 grams:

Labels Topicaine 4% 113 gram tubesLabels Topicaine 4% 113 gram tubes

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1291672lidocaine 4 % Topical GelPSN5
1651001Topicaine 4 % Topical GelPSN5
1651001lidocaine 0.04 MG/MG Topical Gel [Topicaine]SBD5
1291672lidocaine 0.04 MG/MG Topical GelSCD5
1291672lidocaine 4 % Topical GelSY5
1651001Topicaine 4 % Topical GelSY5

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130363135312135GTIN-13: 0363135312135
EAN-13: 0363135312135
GTIN-12: 363135312135
UPC-A: 363135312135
GTIN storage (14 digits): 00363135312135		Box-for-Topicaine-4-10-g-tubes-CDER-1-15-2019.jpg

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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
63135-312-042024-09-21C16284748780-1f386c64a-18de-0266-e053-dadaa90a7c1aTOPICAINE
63135-312-042024-09-21C16284748780-1f386c64a-18de-0266-e053-dadaa90a7c1aTOPICAINE
63135-312-132024-09-21C16284748780-1f386c64a-18de-0266-e053-dadaa90a7c1aTOPICAINE
63135-312-132024-09-21C16284748780-1f386c64a-18de-0266-e053-dadaa90a7c1aTOPICAINE
63135-312-302024-09-21C16284748780-1f386c64a-18de-0266-e053-dadaa90a7c1aTOPICAINE
63135-312-302024-09-21C16284748780-1f386c64a-18de-0266-e053-dadaa90a7c1aTOPICAINE
63135-312-042023-01-30C16284748780-1f386c64a-18de-0266-e053-dadaa90a7c1aTOPICAINE
63135-312-042023-01-30C16284748780-1f386c64a-18de-0266-e053-dadaa90a7c1aTOPICAINE
63135-312-132023-01-30C16284748780-1f386c64a-18de-0266-e053-dadaa90a7c1aTOPICAINE
63135-312-132023-01-30C16284748780-1f386c64a-18de-0266-e053-dadaa90a7c1aTOPICAINE
63135-312-302023-01-30C16284748780-1f386c64a-18de-0266-e053-dadaa90a7c1aTOPICAINE
63135-312-302023-01-30C16284748780-1f386c64a-18de-0266-e053-dadaa90a7c1aTOPICAINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63135-312-04TOPICAINE113 g in 1 TUBEGEL1135
63135-312-13TOPICAINE10 g in 1 TUBEGEL105
63135-312-13TOPICAINE1 in 1 BOXGEL15
63135-312-30TOPICAINE1 in 1 BOXGEL15
63135-312-30TOPICAINE30 g in 1 TUBEGEL305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63135-312-04GM - Gram63135-312477107f9-14e6-49b4-9bc3-5ba2f4b06dfc12015-06-09
63135-312-13GM - Gram63135-3124683b683-a1f1-476f-ba81-ec4e7d0df60912015-06-09
63135-312-30GM - Gram63135-3127cd93361-2de8-46e6-8d3e-cefdcf7482c712015-06-09

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63135-31263135-312-30, 63135-312-13, 63135-312-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOMER 9404Q93RCW27EIACT
ALCOHOL3K9958V90MIACT
JOJOBA OIL724GKU717MIACT
GLYCERYL LAURATEY98611C087IACT
ALOE VERA LEAFZY81Z83H0XIACT
BENZYL ALCOHOLLKG8494WBHIACT
LIDOCAINE98PI200987ACTIB
GLYCERINPDC6A3C0OXIACT
EDETATE DISODIUM7FLD91C86KIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42024-09-19full-release2026-06-01 00:19:57

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
TOPICAINELIDOCAINE 4%ESBA LABORATORIES INC.7f96e980-891e-743d-e053-2a91aa0aea5f2026-01-08WarningsExact identifier
ndc (package): 63135-312-30
ndc (package): 63135-312-04
ndc (package): 63135-312-13
ndc (product): 63135-312
ndc11 (package): 63135031213
ndc11 (package): 63135031204
ndc11 (package): 63135031230
spl id: 47e8cec4-fde0-1956-e063-6394a90a1bdc
spl set id: 7f96e980-891e-743d-e053-2a91aa0aea5f

Reported adverse events (FAERS/openFDA)#

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