FDA.reportPublic FDA data

LUBRICAINE 5

Manufacturer
ESBA LABORATORIES INC.
Effective date
2026-01-28
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:35:34

Label at a glance#

ProductLUBRICAINE 5
Active ingredientLIDOCAINE
Label structure12 sections

Indications and uses

For temporary relief of pain, soreness or burning in the perianal area

Dosage and administration

Cleanse affected area with mild soap and water. Gently dry by patting or blotting with toilet tissue or a soft cloth before application. Apply externally to the affected area up to 6 times daily.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5%

Purpose

OTC - PURPOSE SECTION

Anorectal Anesthetic

Warnings

WARNINGS SECTION

For external use only.

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain, soreness or burning in the perianal area

When using this product

OTC - WHEN USING SECTION

Do not use this product with a mechanical device. Certain persons can develop allergic reactions to ingredients in this product.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Certain persons can develop allergic reactions to ingredients in this product.
  • If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.
  • Do not exceed the daily recommended dosage.
  • In case of bleeding, consult a doctor promptly.
  • As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product.

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

  • Cleanse affected area with mild soap and water. Gently dry by patting or blotting with toilet tissue or a soft cloth before application.
  • Apply externally to the affected area up to 6 times daily.

Other Information

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Anthemis Nobilis (Roman Chamomile) Essential Oil, Benzyl Alcohol, Dehydroacetic Acid, Glycerin, Lactic Acid, Propanediol, Purified Water, Stevia Rebaudiana Extract, Xanthan Gum.

Questions

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label of Tube of Lubricaine - Lidocaine 5%Label of Tube of Lubricaine - Lidocaine 5%

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
63135-924-042024-09-19C16284748780-1f386c649-fbd4-0266-e053-dadaa90a7c1aLUBRICAINE 5
63135-924-042023-01-30C16284748780-1f386c649-fbd4-0266-e053-dadaa90a7c1aLUBRICAINE 5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63135-924-04LUBRICAINE 5113 g in 1 TUBEGEL1135

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63135-924-04GM - Gram63135-9247975322d-b559-447f-a7ac-69fedd8db17212022-11-07

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
63135-92463135-924-04

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
BENZYL ALCOHOLLKG8494WBHIACT
CHAMOMILE FLOWER OIL60F80Z61A9IACT
LACTIC ACID, DL-3B8D35Y7S4IACT
ALLANTOIN344S277G0ZIACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
LIDOCAINE98PI200987ACTIB
XANTHAN GUMTTV12P4NEEIACT
DEHYDROACETIC ACID2KAG279R6RIACT

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
LUBRICAINE 5LIDOCAINE 5%ESBA LABORATORIES INC.9d98afbf-11ce-745b-e053-2a95a90abc142026-01-28WarningsExact identifier
ndc (package): 63135-924-04
ndc (product): 63135-924
ndc11 (package): 63135092404
spl id: 4975492b-5e21-ace9-e063-6394a90a47da
spl set id: 9d98afbf-11ce-745b-e053-2a95a90abc14

Reported adverse events (FAERS/openFDA)#

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