FDA.reportPublic FDA data

FIRST AID BURN

Manufacturer
Epic Medical Supply Corp
Effective date
2024-06-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:13:22

Label at a glance#

ProductFIRST AID BURN
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure9 sections

Indications and uses

For temporary relief of pain and itching associated with: Sunburn Minor burns, Insect bites, Minor skin irritation, Cuts Scrapes

Dosage and administration

Adults and children 2 years and over : clean the affected area apply a small amount of this product on the area 3 to 4 times daily may be covered with a sterile bandage Children under 2 years : consult a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 0.5% Topical Analgesic

Benzalkonium Chloride 0.13% Topical Antiseptic

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Topical Antiseptic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching associated with:

  • Sunburn
  • Minor burns,
  • Insect bites,
  • Minor skin irritation,
  • Cuts
  • Scrapes

Warnings

WARNINGS SECTION

For external use only


Do not use

  • in the eyes 
  • over large areas of the body or on deep puncture wounds, animal bites, or serious burns 
  • in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if 

  • the condition gets worse 
  • condition clears up and recurs within a few days 
  • condition persists for more than 7 days
  • If pregnant or breast feeding, ask a health care professional before use.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years and over: clean the affected area apply a small amount of this product on the area 3 to 4 times daily may be covered with a sterile bandage
  • Children under 2 years: consult a doctor

Other information

SPL UNCLASSIFIED SECTION

  • Store at room temperature 
  • tamper evident sealed packets 
  • do not use any opened or torn packets

Inactive ingredients

INACTIVE INGREDIENT SECTION

Butylated Hydroxytoluene, Cetostearyl Alcohol, Dimethicone, Edetate Disodium, Glycerin, Glyceryl Monostearate, Isopropyl Myristate, Macrogol Cetostearyl Ether 20, Methylcellulose, Purified Water, Sodium Methylparaben, Sodium Propylparaben.

Questions?

SPL UNCLASSIFIED SECTION

Contact: 1.848.373.2075

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN1
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD1
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY1

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
82749-009-01FIRST AID BURN0.9 g in 1 PACKETCREAM0.91
82749-009-01FIRST AID BURN144 in 1 BOXCREAM1441

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82749-009FIRST AID BURN (LIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDE) CREAM [EPIC MEDICAL SUPPLY CORP]1Current NDC, 2 package rows20240606_bd1b1873-e900-45eb-96a0-28f782b5a7cd.zip

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
82749-00982749-009-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIMETHICONE92RU3N3Y1OIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
METHYLCELLULOSE, UNSPECIFIEDZ944H5SN0HIACT
WATER059QF0KO0RIACT
METHYLPARABEN SODIUMCR6K9C2NHKIACT
PROPYLPARABEN SODIUM625NNB0G9NIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
FIRST AID BURNLIDOCAINE HYDROCHLORIDE,BENZALKONIUM CHLORIDEEpic Medical Supply Corpbd1b1873-e900-45eb-96a0-28f782b5a7cd2024-06-04WarningsExact identifier
ndc (package): 82749-009-01
ndc (product): 82749-009
ndc11 (package): 82749000901
spl id: 1a16f726-8d68-59a6-e063-6394a90a9278
spl set id: bd1b1873-e900-45eb-96a0-28f782b5a7cd

Reported adverse events (FAERS/openFDA)#

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