FDA.reportPublic FDA data

4% Lidocaine Gel

Manufacturer
Bellus Medical, LLC
Effective date
2026-01-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
monthly-update
Hydrated at
2026-06-03 17:52:08

Label at a glance#

ProductLidocaine
Active ingredientLIDOCAINE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

INACTIVE INGREDIENT SECTION

Water, Ethyl Alcohol, Glycerin, Propylene Glycol, Xanthan Gum, Phenoxyethanol, Caprylyl Glycol, Aloe Barbadensis (Aloe Vera) Leaf Extract, Sorbic Acid, Tetrasodium EDTA.

DOSAGE & ADMINISTRATION SECTION

USES: For the temporary relief of discomfort and pain associated with

  • Minor burns and skin irritations
  • Minor cuts and scrapes
  • Itching

DIRECTIONS: Adults and Children 12 years of age and older apply to affected area not more than 3-4 times daily.

WARNINGS SECTION

WARNINGS: For external use only. Avoid contact with the eyes.

DO NOT USE: In large quantities particularly over raw sources or blistered areas.

INDICATIONS & USAGE SECTION

USES: For the temporary relief of discomfort and pain associated with

  • Minor burns and skin irritations
  • Minor cuts and scrapes
  • Itching

DIRECTIONS: Adults and Children 12 years of age and older apply to affected area not more than 3-4 times daily.

OTC - PURPOSE SECTION

Topical Anesthetic

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep put of reach of children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BLT_4ml_Packet_L_170613 JPEGBLT_4ml_Packet_L_170613 JPEG

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1291672lidocaine 4 % Topical GelPSN4
1291672lidocaine 0.04 MG/MG Topical GelSCD4
1291672lidocaine 4 % Topical GelSY4

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
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
71888-102-022023-10-27C16284748780-19d75b9d0-4366-f424-e053-dadaa90a57ce4% Lidocaine Gel
71888-102-022023-10-27C16284748780-19d75b9d0-4366-f424-e053-dadaa90a57ce4% Lidocaine Gel
71888-102-022020-01-31C16284748780-19d75b9d0-4366-f424-e053-dadaa90a57ce4% Lidocaine Gel
71888-102-022020-01-31C16284748780-19d75b9d0-4366-f424-e053-dadaa90a57ce4% Lidocaine Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71888-102-01Lidocaine4 mL in 1 PACKETGEL44
71888-102-02Lidocaine12 in 1 BOXGEL124

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
71888-10271888-102-01, 71888-102-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SORBIC ACIDX045WJ989BIACT
EDETATE SODIUMMP1J8420LUIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
XANTHAN GUMTTV12P4NEEIACT
ALOE VERA LEAFZY81Z83H0XIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-11-18full-release2026-06-01 00:37:49

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
LidocaineLIDOCAINEBellus Medical, LLC60cb89f6-e326-0773-e053-2a91aa0a33dd2026-01-09WarningsExact identifier
ndc (package): 71888-102-02
ndc (package): 71888-102-01
ndc (product): 71888-102
ndc11 (package): 71888010201
ndc11 (package): 71888010202
spl id: 47faa8c0-6461-9be9-e063-6394a90a343f
spl set id: 60cb89f6-e326-0773-e053-2a91aa0a33dd