FDA.reportPublic FDA data

Burn Cream

Manufacturer
Trifecta Pharmaceuticals USA LLC
Effective date
2025-08-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:11:56

Label at a glance#

ProductBurn Cream
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure13 sections

Indications and uses

Temporary Relief of pain associated with minor cuts, scrapes and burns. Helps protect against harmful bacteria.

Dosage and administration

Clean the affected area Apply a small amount not more than 3 times daily May be covered with a sterile bandage

Storage and handling

Store in cool dry area 15° to 25°C (59° to 77°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 HCI 0.5%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

Uses

INDICATIONS & USAGE SECTION

Temporary Relief of pain associated with minor cuts, scrapes and burns.

Helps protect against harmful bacteria.

Warnings

WARNINGS SECTION

For external Use Only

Do not use

  • in eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns
  • for more than one week unless directed by a doctor

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the affected area
  • Apply a small amount not more than 3 times daily
  • May be covered with a sterile bandage

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf juice, Cetearyl alcohol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl stearate/PEG-100 stearate, Maltodextrin, Mineral oil, Phenoxyethanol, Propylene glycol, purified water, stearic acid, Triethanolamine.

Questions

OTC - QUESTIONS SECTION

To reorder:

Call 1-760-642-2638

Storage Information

STORAGE AND HANDLING SECTION

  • Store in cool dry area 15° to 25°C (59° to 77°F).
  • tamper evident sealed packets
  • do not use any opened or torn packets

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 immediately.

Other Information

SPL UNCLASSIFIED SECTION

Manufactured for:

Urgent First Aid®

2603 Industry Street

Oceanside, CA. 92054 USA

www.UrgentFirstAid.com

Reorder # URG-400

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

URG-400 BURN CREAM 0.9G 25PK 072225 CDERURG-400 BURN CREAM 0.9G 25PK 072225 CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN4
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD4
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY4

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
69396-124-09Burn Cream25 in 1 CARTONCREAM254
69396-124-09Burn Cream0.9 g in 1 PACKETCREAM0.94

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-12469396-124-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
TROLAMINE9O3K93S3TKIACT
MALTODEXTRIN7CVR7L4A2DIACT
MINERAL OILT5L8T28FGPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARIC ACID4ELV7Z65APIACT
GLYCERINPDC6A3C0OXIACT
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
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCITrifecta Pharmaceuticals USA LLCfe439c60-5a02-648f-e053-6294a90a14032025-08-23WarningsExact identifier
ndc (package): 69396-124-09
ndc (product): 69396-124
ndc11 (package): 69396012409
spl id: 3d0f0b60-9ea4-700a-e063-6294a90a0d27
spl set id: fe439c60-5a02-648f-e053-6294a90a1403

Reported adverse events (FAERS/openFDA)#

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