FDA.reportPublic FDA data

TOPICAINE 5

Manufacturer
ESBA LABORATORIES INC.
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
monthly-update
Hydrated at
2026-06-03 17:52:12

Label at a glance#

ProductTOPICAINE 5
Active ingredientLIDOCAINE
Label structure7 sections

Indications and uses

For the temporary relief of pain and itching due to anorectal disorders.

Dosage and administration

When practical, clean area with mild soap and warm water and rinse thoroughly Gently dry by patting or blotting with toilet tissue or soft cloth before applying Adults and children 12 years old and older: Apply externally to the affected area up to 6 times a day Children under 12 years of age: consult a doctor.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5% w/w

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching due to anorectal disorders.

Warnings

WARNINGS SECTION

For external use only

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

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas
  • do not put in rectum
  • do not exceed recommended dosage unless directed by a doctor

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • allergic reaction occurs
  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase.

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.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • When practical, clean area with mild soap and warm water and rinse thoroughly
  • Gently dry by patting or blotting with toilet tissue or soft cloth before applying
  • Adults and children 12 years old and older: Apply externally to the affected area up to 6 times a day
  • Children under 12 years of age: consult a doctor.

Label on tube and outer carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Labeling printed on tube of Topicaine 5% 10 g

Printed tube of Topicaine 5% 10 gramsPrinted tube of Topicaine 5% 10 grams

Outer carton of Topicaine 5% 10 g tube

Outer carton of Topicaine 5% 10 g tubesOuter carton of Topicaine 5% 10 g tubes

Label affixed to tube of Topicaine 5 % 30 g tube

TOP5-030 labelTOP5-030 label

Outer carton of Topicaine 5 % 30 g tube:

Topicaine 5 30 g outer carton updateTopicaine 5 30 g outer carton update

Label affixed to tube to Topicaine 5% 113 g

Label of tube of Topicaine 5% 113 gLabel of tube of Topicaine 5% 113 g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1652104lidocaine 5 % Rectal GelPSN11
1652108Topicaine-5 5 % Rectal GelPSN11
1652108lidocaine 0.05 MG/MG Rectal Gel [Topicaine]SBD11
1652104lidocaine 0.05 MG/MG Rectal GelSCD11
1652104lidocaine 5 % Rectal GelSY11
1652108Topicaine 0.05 MG/MG Rectal GelSY11
1652108Topicaine-5 5 % Rectal GelSY11

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-130363135581302GTIN-13: 0363135581302
EAN-13: 0363135581302
GTIN-12: 363135581302
UPC-A: 363135581302
GTIN storage (14 digits): 00363135581302		Top-5-30-g-outer-carton-labeling-update-1-15-2019-CDER.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
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63135-581-04TOPICAINE 5113 g in 1 TUBEGEL11311
63135-581-10TOPICAINE 51 in 1 BOXGEL111
63135-581-10TOPICAINE 510 g in 1 TUBEGEL1011
63135-581-30TOPICAINE 530 g in 1 TUBEGEL3011
63135-581-30TOPICAINE 51 in 1 BOXGEL111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63135-581-04GM - Gram63135-581516d8cdc-b0b9-41d0-a09e-16adb6e54e5512015-06-09
63135-581-10GM - Gram63135-58152ce08c1-dd51-40ca-ac6b-e384ded7cd4112022-06-06
63135-581-30GM - Gram63135-581327039a8-0a8b-4662-a224-14eee8dc7f7712015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LIDOCAINEACTIVE INGREDIENT98PI2009872
LIDOCAINEACTIVE MOIETY98PI2009872
.ALPHA.-BISABOLOL, (+/-)-INACTIVE INGREDIENT36HQN158VC2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH2
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27E2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
GLYCERYL LAURATEINACTIVE INGREDIENTY98611C0872
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y2

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63135-58163135-581-30, 63135-581-10, 63135-581-04

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
GLYCERINPDC6A3C0OXIACT
LIDOCAINE98PI200987ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
BENZYL ALCOHOLLKG8494WBHIACT
.ALPHA.-BISABOLOL, (+/-)-36HQN158VCIACT
SHEA BUTTERK49155WL9YIACT
EDETATE DISODIUM7FLD91C86KIACT
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT
GLYCERYL LAURATEY98611C087IACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102024-09-19full-release2026-06-01 00:19:46

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CARBOMER 940CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CARBOMER 940CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERYL LAURATEGLYCERYL LAURATEY98611C087SYSTEM / TOPICAL4 mgExact identifier — unii+route
4 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / TOPICAL185 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERYL LAURATEGLYCERYL LAURATEY98611C087SYSTEM / TOPICAL4 mgExact identifier — unii+route
4 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / TOPICAL185 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SHEA BUTTERSHEA BUTTERK49155WL9YLOTION / TOPICAL2340 mgExact identifier — unii+route
4 equally ranked IID candidates
GLYCERYL LAURATEGLYCERYL LAURATEY98611C087SYSTEM / TOPICAL4 mgExact identifier — unii+route
4 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / TOPICAL185 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SHEA BUTTERSHEA BUTTERK49155WL9YLOTION / TOPICAL2340 mgExact identifier — unii+route
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CARBOMER 940CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERYL LAURATEGLYCERYL LAURATEY98611C087SYSTEM / TOPICAL4 mgExact identifier — unii+route
4 equally ranked IID candidates
SHEA BUTTERSHEA BUTTERK49155WL9YLOTION / TOPICAL2340 mgExact identifier — unii+route
4 equally ranked IID candidates
CARBOMER 940CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SHEA BUTTERSHEA BUTTERK49155WL9YLOTION / TOPICAL2340 mgExact identifier — unii+route
4 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / TOPICAL185 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates

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
TOPICAINE 5LIDOCAINE 5%ESBA LABORATORIES INC.15d33ff7-34ed-253d-e054-00144ff88e882026-01-08WarningsExact identifier
ndc (package): 63135-581-30
ndc (package): 63135-581-04
ndc (package): 63135-581-10
ndc (product): 63135-581
ndc11 (package): 63135058130
ndc11 (package): 63135058104
ndc11 (package): 63135058110
spl id: 47e9cb0c-dbdb-3ee0-e063-6394a90a9052
spl set id: 15d33ff7-34ed-253d-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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