FDA.reportPublic FDA data

LIPOCAINE 5

Manufacturer
ESBA LABORATORIES INC. | Esba Laboratories Inc
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
monthly-update
Hydrated at
2026-06-03 17:52:26

Label at a glance#

ProductLIPOCAINE 5
Active ingredientLIDOCAINE
Label structure9 sections

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%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

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 (1-800-222-1222).

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.

Other information:

OTHER SAFETY INFORMATION

  • Store at room temperature 20-25oC (68-77oF).
  • Child-Resistant Cap: push down and turn to open
  • Available in 1 Oz (30 g) and 4 Oz (113 g) tubes

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf Extract, Beta-Sitosterol, Caprylhydroxamic Acid, Cetyl Alcohol, Cetyl Palmitate, Glycerin, Glyceryl Caprylate, Isostearyl Alcohol, Lecithin, Purified Water, Sucrose Distearate, Sucrose Stearate , Tocopheryl Acetate, Triethylcitrate, Xanthan Gum.

Questions

OTC - QUESTIONS SECTION

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

Label on tube and outer carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lipocaine 5 tube 113 grams label

Lipocaine 5- tube 113 grams labelLipocaine 5- tube 113 grams label

Lipocaine 5 tube 30 grams label

Label Lipocaine 5 - 30 g tubeLabel Lipocaine 5 - 30 g tubeOuter carton of Lipocaine 5 - 30 g tube

Outer carton Lipocaine 5 - 30 g tubeOuter carton Lipocaine 5 - 30 g tube

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1534792lidocaine 5 % Topical CreamPSN7
2120175LIPOCAINE 5 % Topical CreamPSN7
2120175lidocaine 50 MG/ML Topical Cream [Lipocaine]SBD7
1534792lidocaine 50 MG/ML Topical CreamSCD7
1534792lidocaine 5 % Topical CreamSY7
2120175Lipocaine 50 MG/ML Topical CreamSY7

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-130606604811303GTIN-13: 0606604811303
EAN-13: 0606604811303
GTIN-12: 606604811303
UPC-A: 606604811303
GTIN storage (14 digits): 00606604811303		Box-for-Lipocaine-30-g-tubes-rev1-x-1200fda.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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63135-811-042024-09-19C16284748780-1f386c649-9fd3-0266-e053-dadaa90a7c1aLIPOCAINE 5
63135-811-042024-09-19C16284748780-1f386c649-9fd3-0266-e053-dadaa90a7c1aLIPOCAINE 5
63135-811-302024-09-19C16284748780-1f386c649-9fd3-0266-e053-dadaa90a7c1aLIPOCAINE 5
63135-811-302024-09-19C16284748780-1f386c649-9fd3-0266-e053-dadaa90a7c1aLIPOCAINE 5
63135-811-042023-01-30C16284748780-1f386c649-9fd3-0266-e053-dadaa90a7c1aLIPOCAINE 5
63135-811-042023-01-30C16284748780-1f386c649-9fd3-0266-e053-dadaa90a7c1aLIPOCAINE 5
63135-811-302023-01-30C16284748780-1f386c649-9fd3-0266-e053-dadaa90a7c1aLIPOCAINE 5
63135-811-302023-01-30C16284748780-1f386c649-9fd3-0266-e053-dadaa90a7c1aLIPOCAINE 5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63135-811-04LIPOCAINE 5113 g in 1 TUBECREAM1137
63135-811-30LIPOCAINE 530 g in 1 TUBECREAM307
63135-811-30LIPOCAINE 51 in 1 CARTONCREAM17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63135-811-04GM - Gram63135-811d8c8286f-ca85-4463-9cac-97660d74e5d012022-11-07
63135-811-30GM - Gram63135-8111401993b-4b9f-41e7-a7b8-4b289cd6a39a12022-11-07

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63135-81163135-811-30, 63135-811-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
XANTHAN GUMTTV12P4NEEIACT
SUCROSE DISTEARATE33X4X4B90SIACT
.BETA.-SITOSTEROLS347WMO6M4IACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
GLYCERINPDC6A3C0OXIACT
CETYL PALMITATE5ZA2S6B08XIACT
CETYL ALCOHOL936JST6JCNIACT
WATER059QF0KO0RIACT
ISOSTEARYL ALCOHOLQ613OCQ44YIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
SUCROSE STEARATE274KW0O50MIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
ALOE VERA LEAFZY81Z83H0XIACT
LIDOCAINE98PI200987ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62024-09-19full-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
LIPOCAINE 5LIDOCAINE 5%ESBA LABORATORIES INC.849d6e28-a6b8-7f49-e053-2a91aa0a497d2026-01-08WarningsExact identifier
ndc (package): 63135-811-04
ndc (package): 63135-811-30
ndc (product): 63135-811
ndc11 (package): 63135081104
ndc11 (package): 63135081130
spl id: 47e9b048-94f7-0cfc-e063-6394a90ab0ae
spl set id: 849d6e28-a6b8-7f49-e053-2a91aa0a497d

Reported adverse events (FAERS/openFDA)#

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