FDA.reportPublic FDA data

Burn Cream

Manufacturer
Trifecta Pharmaceuticals USA LLC
Effective date
2024-03-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:09:30

Label at a glance#

ProductBurn Cream
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure14 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 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

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

Call: 1-888-296-9067

Storage Information

STORAGE AND HANDLING SECTION

  • Store in cool dry area 15° to 25°C (59° to 79°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

Distributed By:

Trifecta Pharmaceuticals USA®

101 NE Third Ave. Ste 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

R519-541 GLOBE FIRST AID BURN CREAM 0.9G 25PK 112823 CDERR519-541 GLOBE FIRST AID BURN CREAM 0.9G 25PK 112823 CDER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

R519-539 GLOBE FIRST AID BURN CREAM 0.9G 10CT 112823 CDERR519-539 GLOBE FIRST AID BURN CREAM 0.9G 10CT 112823 CDER

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
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
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
69396-146-10Burn Cream0.9 g in 1 PACKETCREAM0.91
69396-146-10Burn Cream10 in 1 CARTONCREAM101
69396-146-25Burn Cream0.9 g in 1 PACKETCREAM0.91
69396-146-25Burn Cream25 in 1 CARTONCREAM251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-146BURN CREAM (BENZALKONIUM CHLORIDE, LIDOCAINE HCI) CREAM [TRIFECTA PHARMACEUTICALS USA LLC]1Current NDC, 4 package rows20240308_1308ce91-2858-310a-e063-6394a90a6810.zip

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
69396-14669396-146-10, 69396-146-25

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
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALOE VERA LEAFZY81Z83H0XIACT
MINERAL OILT5L8T28FGPIACT
STEARIC ACID4ELV7Z65APIACT
GLYCERINPDC6A3C0OXIACT
TROLAMINE9O3K93S3TKIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
MALTODEXTRIN7CVR7L4A2DIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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 LLC1308ce91-2858-310a-e063-6394a90a68102024-03-06WarningsExact identifier
ndc (package): 69396-146-10
ndc (package): 69396-146-25
ndc (product): 69396-146
ndc11 (package): 69396014625
ndc11 (package): 69396014610
spl id: 130896d1-aaca-5932-e063-6394a90aba9f
spl set id: 1308ce91-2858-310a-e063-6394a90a6810

Reported adverse events (FAERS/openFDA)#

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