FDA.reportPublic FDA data

Burn First Aid

Manufacturer
Dynarex Corporation
Effective date
2024-01-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:07:45

Label at a glance#

ProductBurn First Aid
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure12 sections

Indications and uses

For the 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

Storage and handling

store in a cool, dry area 15°-25° C (59°-79° F) tamper evident sealed packets do not use any opened or torn packets

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 0.5%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Topical antiseptic

Uses

INDICATIONS & USAGE SECTION

For the 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

OTC - DO NOT USE SECTION

  • 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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care professional before use.

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

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

STORAGE AND HANDLING SECTION

  • store in a cool, dry area 15°-25° C (59°-79° F)
  • tamper evident sealed packets
  • do not use any opened or torn packets

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Butylated Hydroxytoluene, Cetomacrogol, Cetostearyl Alcohol, Dimethicone, Glycerine, Glyceryl Monostearate, Isopropyl Myristate, Methylcellulose, Purified Water, Sodium EDTA, Sodium Methylparaben, Sodium Propylparaben

1165 Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1165 First Aid Burn Cream1165 First Aid Burn Cream

1165UB-10 Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1165UB-10_BX_MASTER1165UB-10_BX_MASTER1165UB-10

1165UB-25 Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1165UB-25_BX_MASTER1165UB-25_BX_MASTER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN3
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD3
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY3

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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
67777-007-49Burn First Aid900 mg in 1 PACKETCREAM9003
67777-007-49Burn First Aid144 in 1 BOXCREAM1443
67777-007-50Burn First Aid1728 in 1 CASECREAM17283
67777-007-51Burn First Aid10 in 1 BOXCREAM103
67777-007-51Burn First Aid900 mg in 1 PACKETCREAM9003
67777-007-52Burn First Aid1000 in 1 CASECREAM10003
67777-007-53Burn First Aid25 in 1 BOXCREAM253
67777-007-53Burn First Aid900 mg in 1 PACKETCREAM9003
67777-007-54Burn First Aid1800 in 1 CASECREAM18003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-007BURN FIRST AID CREAM [DYNAREX CORPORATION]3Current NDC, Legacy NDC, 9 package rows20240124_826e08be-dffa-5a27-e053-2a91aa0a8701.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-007-49EA - Each67777-007894fb057-3e14-408d-91c4-e93a059f458d12023-07-06
67777-007-50EA - Each67777-00770737ce6-302d-4cb4-88d6-786b0bd30efe12023-07-06

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
67777-00767777-007-49, 67777-007-50, 67777-007-51, 67777-007-52, 67777-007-53, 67777-007-54

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
EDETATE SODIUMMP1J8420LUIACT
METHYLPARABEN SODIUMCR6K9C2NHKIACT
PROPYLPARABEN SODIUM625NNB0G9NIACT
CETETH-20I835H2IHHXIACT
METHYLCELLULOSE (4000 CPS)MRJ667KA5EIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
DIMETHICONE 3502Y53S6ATLUIACT

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
Burn First AidBURN FIRST AIDDynarex Corporation826e08be-dffa-5a27-e053-2a91aa0a87012024-01-22WarningsExact identifier
ndc (package): 67777-007-52
ndc (package): 67777-007-49
ndc (package): 67777-007-51
ndc (package): 67777-007-53
ndc (package): 67777-007-50
ndc (package): 67777-007-54
ndc (product): 67777-007
ndc11 (package): 67777000754
ndc11 (package): 67777000753
ndc11 (package): 67777000749
ndc11 (package): 67777000750
ndc11 (package): 67777000751
ndc11 (package): 67777000752
spl id: 0f907def-a9d1-3e58-e063-6294a90a641b
spl set id: 826e08be-dffa-5a27-e053-2a91aa0a8701

Reported adverse events (FAERS/openFDA)#

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