FDA.reportPublic FDA data

Burn

Manufacturer
Yiwu Ori-Power Medtech Co., Ltd.
Effective date
2023-08-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:56:00

Label at a glance#

ProductBurn
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure7 sections

Indications and uses

Temporary pain relief associated with minor burns.

Dosage and administration

Apply an even layer of burn gel over deaned affected area not more than 3-4 times daily not to be used on children under 12 years of age.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride 2%

Purpose

OTC - PURPOSE SECTION

Topical pain relief

Uses

INDICATIONS & USAGE SECTION

Temporary pain relief associated with minor burns.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in large quantities, particularly over raw or blistered areas.
  • near eyes, if this happens rinse thoroughly with water.

Stop use and ask a doctor

OTC - STOP USE SECTION

if the condition worsens or persists for more than 7 days or clears up and returns.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply an even layer of burn gel over deaned affected area not more than 3-4 times daily
  • not to be used on children under 12 years of age.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe BarbadensisLeaf Juice, Carbomer, Ethylhexgilglycerin, Maltodextrin, Menthol, Polyethylene Glycol, Phenoxyethanol, Triethanolamine, Tocopheryl Acetate, Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of pouch labelimage of pouch label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1011852lidocaine HCl 2 % Topical GelPSN1
1011852lidocaine hydrochloride 0.02 MG/MG Topical GelSCD1
1011852lidocaine hydrochloride 2 % Topical JellySY1

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
72459-101-012025-01-30C16284748780-12cef2736-7617-d83d-e063-dadaa90ab31f03f3c281-542b-6fca-e063-6394a90abec5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72459-101-01Burn0.9 g in 1 POUCHGEL0.91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72459-101BURN (LIDOCAINE HYDROCHLORIDE) GEL [YIWU ORI-POWER MEDTECH CO., LTD.]11 package rows20230828_03f3c281-542b-6fca-e063-6394a90abec5.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72459-10172459-101-01

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
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
MALTODEXTRIN7CVR7L4A2DIACT
MENTHOLL7T10EIP3AIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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
03f3c281-542c-6fca-e063-6394a90abec503f3c281-542b-6fca-e063-6394a90abec52023-08-27WarningsExact identifier
spl id: 03f3c281-542c-6fca-e063-6394a90abec5
spl set id: 03f3c281-542b-6fca-e063-6394a90abec5

Reported adverse events (FAERS/openFDA)#

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