FDA.reportPublic FDA data

First Aid Burn Cream

Manufacturer
ProStat First Aid LLC
Effective date
2025-12-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:25:32

Label at a glance#

ProductFirst Aid Burn Cream
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure10 sections

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 Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride 0.5%

Purpose

OTC - PURPOSE SECTION

Benzalkonium Chloride Topical Antiseptic

Lidocaine Hydrochloride Topical Analgesic

Use(s)

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 dioctor 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.

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

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

OTHER SAFETY INFORMATION

• Store in a cool, dry area 15º-25ºC (59º-77ºF)

• Tamper evident sealed packets

• Do not use any opened or torn packets

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Butylated Hydroxytoluene, Cetomacrogol 1000, Cetostearyl Alcohol, Dimethicone, Glycerine, Glyceryl Monostearate, Isopropyl Myristate, Methylcellulose, Purified Water, Sodium EDTA, Sodium Methylparaben, Sodium Propylparaben

Questions?

OTC - QUESTIONS SECTION

1-888-900-2920 Monday - Friday 8AM - 4PM PST.

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PS-2044-BX-MASTERPS-2044-BX-MASTERFirst Aid Burn Cream

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130814889010186GTIN-13: 0814889010186
EAN-13: 0814889010186
GTIN-12: 814889010186
UPC-A: 814889010186
GTIN storage (14 digits): 00814889010186		PS-2044-BX-MASTER-R230123-11.jpg

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
58228-2044-1First Aid Burn Cream0.9 g in 1 PACKETCREAM0.93
58228-2044-1First Aid Burn Cream25 in 1 BOXCREAM253
58228-2044-2First Aid Burn Cream1800 in 1 CASECREAM18003

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58228-204458228-2044-1, 58228-2044-2

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
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
METHYLPARABEN SODIUMCR6K9C2NHKIACT
PROPYLPARABEN SODIUM625NNB0G9NIACT
METHYLCELLULOSE (4000 CPS)MRJ667KA5EIACT
WATER059QF0KO0RIACT
EDETATE SODIUMMP1J8420LUIACT
CETETH-20I835H2IHHXIACT
DIMETHICONE 3502Y53S6ATLUIACT
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 Burn CreamFIRST AID BURN CREAMProStat First Aid LLCf70a442e-7ba7-4860-e053-6394a90ac2bd2025-12-15WarningsExact identifier
ndc (package): 58228-2044-1
ndc (package): 58228-2044-2
ndc (product): 58228-2044
ndc11 (package): 58228204402
ndc11 (package): 58228204401
spl id: 4600f8e1-c2af-56af-e063-6394a90a3ea6
spl set id: f70a442e-7ba7-4860-e053-6394a90ac2bd

Reported adverse events (FAERS/openFDA)#

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