FDA.reportPublic FDA data

Jelcaine Sterile

Manufacturer
Brookfield Pharmaceuticals, LLC
Effective date
2025-11-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:43:04

Label at a glance#

ProductJelcaine Sterile
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

For temporary relief of pain and itching due to: minor cuts sunburn minor scrapes minor burns insect bites minor skin irritations

Dosage and administration

Adults and children 2 years of age and older: Apply externally to the affected area not more than 3-4 time daily. Children under 2 years of age: Do not use. Consult a doctor.

Storage and handling

Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 2% w/v

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching due to:

  • minor cuts
  • sunburn
  • minor scrapes
  • minor burns
  • insect bites
  • minor skin irritations

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.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • allergic reaction occurs
  • condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor
  • you experience any redness, irritation, swelling, pain or other symptoms begin or increase

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

PACKAGE NOT CHILD RESISTANT. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: Apply externally to the affected area not more than 3-4 time daily.
  • Children under 2 years of age: Do not use. Consult a doctor.

Other information

STORAGE AND HANDLING SECTION

  • Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F). See USP Controlled Room Temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

hypromellose, methylparaben, propylparaben, sodium hydroxide. May also contain hydrochloric acid to adjust pH.

Jelcaine Sterile (Lidocaine HCl Jelly USP) 2%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Jelcaine Sterile (Lidocaine HCl Jelly USP (2%)Jelcaine Sterile (Lidocaine HCl Jelly USP (2%)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1011852lidocaine HCl 2 % Topical GelPSN2
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCD2
1011852lidocaine hydrochloride 2 % Topical JellySY2

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-130371351025302GTIN-13: 0371351025302
EAN-13: 0371351025302
GTIN-12: 371351025302
UPC-A: 371351025302
GTIN storage (14 digits): 00371351025302		Jelcaine Carton.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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71351-025-30Jelcaine Sterile30 mL in 1 TUBEJELLY302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71351-025-30ML - Milliliter71351-0258e17f637-f772-4d45-a207-e6f7d903fa0212024-10-04

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71351-02571351-025-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROCHLORIC ACIDQTT17582CBIACT
METHYLPARABENA2I8C7HI9TIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYPROMELLOSES3NXW29V3WOIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12024-08-28full-release2026-06-01 00:19:07

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
Jelcaine SterileLIDOCAINE HCL JELLY USP, 2%Brookfield Pharmaceuticals, LLC1a39d1de-7aa2-3068-e063-6394a90aed852025-11-10WarningsExact identifier
ndc (package): 71351-025-30
ndc (product): 71351-025
ndc11 (package): 71351002530
spl id: 433faabc-d940-29cd-e063-6294a90a4787
spl set id: 1a39d1de-7aa2-3068-e063-6394a90aed85

Reported adverse events (FAERS/openFDA)#

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