FDA.reportPublic FDA data

0.5% LIDOCAINE BURN RELIEF GEL

Manufacturer
Universal Distribution Center LLC
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:36:24

Label at a glance#

Product0.5% LIDOCAINE BURN RELIEF
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

for the temporary relief of pain and itching associated with • minor burns • sunburn • minor cuts • scrapes • insect bites • minor skin irritations

Dosage and administration

• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily • children under 2 years of age: ask a doctor

Storage and handling

Store a room temperature • Protect from direct sunlight.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 0.5%

Purpose

OTC - PURPOSE SECTION

External analgesic

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of pain and itching associated with • minor burns • sunburn • minor cuts • scrapes • insect bites • minor skin irritations

Warnings

WARNINGS SECTION

For external use only

Do not use in large quantities, particularly over raw surfaces or blistered areas

When using this product avoid contact with the eyes

Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 to affected area not more than 3 to 4 times daily • children under 2 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

Store a room temperature • Protect from direct sunlight.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Carbomer, Disodium EDTA, Ethylhexylglycerin, FD&C Blue NO.1, FD&C Yellow NO.5, Glycerin, Menthol, Maltodextrin, Propanediol, Polysorbate 20, Phenoxyethanol, Sodium Hydroxide, SD Alcohol, Water.

SPL UNCLASSIFIED SECTION

✓ Soothes & Cools Minor Burns

✓ Menthol Formula for Fast Pain Relief

✓ Helps Prevent Infection

PAIN RELIEVING GEL WITH ALOE

Mfd for and Distributed by:
Universal Distribution Center LLC
330 Applegarth Road, Monroe Township, NJ 08831
www.universaldc.com

MADE IN CHINA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0.5% LIDOCAINE BURN RELIEF0.5% LIDOCAINE BURN RELIEF

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1011849lidocaine HCl 0.5 % Topical GelPSN1
1011849lidocaine hydrochloride 0.005 MG/MG Topical GelSCD1
1011849lidocaine hydrochloride 0.5 % Topical GelSY1

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-130676979560380GTIN-13: 0676979560380
EAN-13: 0676979560380
GTIN-12: 676979560380
UPC-A: 676979560380
GTIN storage (14 digits): 00676979560380		52000437-6.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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
52000-437-080.5% LIDOCAINE BURN RELIEF226 g in 1 BOTTLE, PLASTICGEL2261
52000-437-080.5% LIDOCAINE BURN RELIEF3 in 1 BOXGEL31

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
52000-43752000-437-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
ALOE VERA LEAF JUICERUE8E6T4NBIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
GLYCERINPDC6A3C0OXIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
MALTODEXTRIN7CVR7L4A2DIACT
PROPANEDIOL5965N8W85TIACT
POLYSORBATE 207T1F30V5YHIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM HYDROXIDE55X04QC32IIACT
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

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
0.5% LIDOCAINE BURN RELIEFLIDOCAINE HYDROCHLORIDEUniversal Distribution Center LLC0a1aeff0-bade-457b-a0ac-099d646c0b2e2026-01-08WarningsExact identifier
ndc (package): 52000-437-08
ndc (product): 52000-437
ndc11 (package): 52000043708
spl id: 7c908ad5-a800-4dc7-8d3c-19b2824fa484
spl set id: 0a1aeff0-bade-457b-a0ac-099d646c0b2e

Reported adverse events (FAERS/openFDA)#

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