FDA.reportPublic FDA data

LUBRICAINE

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 17:51:40

Label at a glance#

ProductLUBRICAINE
Active ingredientLIDOCAINE
Label structure12 sections

Indications and uses

For the temporary relief of pain and itching

Dosage and administration

Adults and children 12 years and older: apply a fingertip amount (approximately 1 inch strip) to affected area no more than 3 to 4 times a day

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 and itching

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • do not use in or near the eye
  • do not use in large quantities, particularly over raw surfaces or blistered areas
  • do not exceed recommended dosage unless directed by a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • allergic reaction occurs
  • condition worsens or does not improve within seven 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 (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and older: apply a fingertip amount (approximately 1 inch strip) to affected area no more than 3 to 4 times a day

Other Information

OTHER SAFETY INFORMATION

  • Store at room temperature 20-25 oC (68-77 oF)
  • Tamper evident: do not use if foil under cap is damaged or mising.
  • Child-Resistant Cap: push down and turn to open

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Citric Acid, Dehydroacetic Acid, Dipotassium Glycyrrhizinate, Lactic Acid, Natural Flavors, Potassium Sorbate, Purified Water, Stevia Rebaudiana Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Xanthan Gum.

Questions

OTC - QUESTIONS SECTION

Call toll-free in USA & Canada 800-677-9299 9 am to 5 pm Eastern Time M-F or visit www.esbalabs.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label of tube of Lubricaine 113 gLabel of tube of Lubricaine 113 g

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
63135-727-042024-09-19C16284748780-1f386c649-fd5c-0266-e053-dadaa90a7c1aLUBRICAINE
63135-727-042024-09-19C16284748780-1f386c649-fd5c-0266-e053-dadaa90a7c1aLUBRICAINE
63135-727-042023-01-30C16284748780-1f386c649-fd5c-0266-e053-dadaa90a7c1aLUBRICAINE
63135-727-042023-01-30C16284748780-1f386c649-fd5c-0266-e053-dadaa90a7c1aLUBRICAINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63135-727-04LUBRICAINE113 g in 1 TUBEGEL1135

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63135-727-04GM - Gram63135-7275014bdbf-a2b0-4657-bb98-dc6e6649aaa112022-11-07

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63135-72763135-727-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CRANBERRY0MVO31Q3QSIACT
LACTIC ACID, DL-3B8D35Y7S4IACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
BENZYL ALCOHOLLKG8494WBHIACT
DEHYDROACETIC ACID2KAG279R6RIACT
VANILLAQ74T35078HIACT
ALOE VERA LEAFZY81Z83H0XIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
XANTHAN GUMTTV12P4NEEIACT
ALLANTOIN344S277G0ZIACT
LIDOCAINE98PI200987ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42024-09-19full-release2026-06-01 00:19:53

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
LUBRICAINELIDOCAINE 4%ESBA LABORATORIES INC.9d7416b1-607d-34e0-e053-2a95a90aa3c32026-01-08WarningsExact identifier
ndc (package): 63135-727-04
ndc (product): 63135-727
ndc11 (package): 63135072704
spl id: 47e9bd07-b72c-08ef-e063-6294a90a7389
spl set id: 9d7416b1-607d-34e0-e053-2a95a90aa3c3

Reported adverse events (FAERS/openFDA)#

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