FDA.reportPublic FDA data

58228-6212-1 FL 8610 Burn Ease Burn gel 0.9g

Manufacturer
ProStat First Aid LLC | Nantong Health & Beyond Hygienic Products Inc.
Effective date
2025-10-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:15:27

Label at a glance#

ProductFL Burn Ease, 0.9g
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

Apply an even layer of burn gel over cleaned 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

Use(s)

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

• any opened or torn packets

• in large quantities, particularly over raw or blistered areas

  • Near eyes. If this happens, rinse thoroughly with water

Stop use and ask a doctor if

OTC - STOP USE SECTION

• 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply an even layer of burn gel over cleaned affected area not more than 3-4 times daily

Not to be used on children under 12 years of age

Other Information

OTHER SAFETY INFORMATION

• store at 68-77F (20-25C)

  • tamper evident sealed packets

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Aminomethyl propanol, Carbomer, Ethylhexylglycerin, Maltodextrin, Menthol, Polyethylene glycol, Phenoxyethanol, Tocopheryl Acetate, Water

Questions?

OTC - QUESTIONS SECTION

1-888-900-2920 8AM - 4PM PST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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

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
58228-6212-1FL Burn Ease, 0.9g900 in 1 CARTONGEL9002
58228-6212-1FL Burn Ease, 0.9g25 in 1 BOXGEL252

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
58228-621258228-6212-1

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
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
AMINOMETHYL PROPANOLLU49E6626QIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
MALTODEXTRIN7CVR7L4A2DIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
MENTHOLL7T10EIP3AIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
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
FL Burn Ease, 0.9gLIDOCAINEProStat First Aid LLC4dc0d579-ab42-4ea5-9788-5e54d7d318a32025-10-01WarningsExact identifier
ndc (package): 58228-6212-1
ndc (product): 58228-6212
ndc11 (package): 58228621201
spl id: 401268c4-5ab2-e37c-e063-6394a90a05a9
spl set id: 4dc0d579-ab42-4ea5-9788-5e54d7d318a3

Reported adverse events (FAERS/openFDA)#

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