FDA.reportPublic FDA data

43473-062 PO First Aid Series Burn Gel

Manufacturer
Nantong Health & Beyond Hygienic Products Inc.
Effective date
2024-12-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:41:13

Label at a glance#

ProductPO First Aid Series BURN
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Lidocaine HCI         2%

OTC - PURPOSE SECTION

Purpose

Topical Pain Relief

INDICATIONS & USAGE SECTION

Uses

Temporary relief of pain associated with minor burns.

WARNINGS SECTION

Warnings

For external use only.

OTC - DO NOT USE SECTION

Do not use

■ in large quantities, particularly over raw or blistered areas

■ near eyes, if this happens rinse thoroughly with water

OTC - STOP USE SECTION

Stop use and ask a doctorif the condition worsens or persists for more than 7 days or clears up and returns

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

DOSAGE & ADMINISTRATION SECTION

Directions

■ 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 INGREDIENT SECTION

Inactive ingredients

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43473-062-01PO First Aid Series BURN0.9 g in 1 PACKETGEL0.91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43473-062PO FIRST AID SERIES BURN (LIDOCAINE HYDROCHLORIDE) GEL [NANTONG HEALTH & BEYOND HYGIENIC PRODUCTS INC.]1Current NDC, 1 package rows20241208_f1c349a8-216d-4233-922e-c95329a33d1e.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
43473-06243473-062-01

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
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER 934Z135WT9208IACT
MENTHOLL7T10EIP3AIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
MALTODEXTRIN7CVR7L4A2DIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TRICLOSAN4NM5039Y5XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
PO First Aid Series BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.f1c349a8-216d-4233-922e-c95329a33d1e2024-12-05WarningsExact identifier
ndc (package): 43473-062-01
ndc (product): 43473-062
ndc11 (package): 43473006201
spl id: 288e4d5d-ed55-2714-e063-6394a90a013a
spl set id: f1c349a8-216d-4233-922e-c95329a33d1e

Reported adverse events (FAERS/openFDA)#

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