FDA.reportPublic FDA data

Antiseptic

Manufacturer
Total Resources International
Effective date
2025-04-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:00:28

Label at a glance#

ProductBurn Cream
Active ingredientbenzalkonium chloride, lidocaine hydrochloride
Label structure7 sections

Indications and uses

temporary relief of pain associated with minor burns helps protect against harmful bacteria

Dosage and administration

clean affected area apply small amount not more than 3 times daily children under 2: consult a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13% w/w

Lidocaine HCI 0.5% w/w

Purposes

OTC - PURPOSE SECTION

First aid antiseptic

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

  • temporary relief of pain associated with minor burns
  • helps protect against harmful bacteria

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

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

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If ingested contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean affected area
  • apply small amount not more than 3 times daily
  • children under 2: consult a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aloe vera, emulsifying wax, ethyl alcohol, methylparaben, mineral oil, paraffin, propylparaben, purified water, white petrolatum, white wax

Principal Display Panel – 0.03 oz Pouch Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BE SMART

GET PREPARED®

BURN CREAM

0.03 oz [0.90 g]

Single Use

Made in USA

Manufactured for Total Resources Intl. Inc.

Walnut, California 91789

www.besmartgetprepared.com • 00-BUR-0009 Rev. 03

NDC 55550-902-21

Principal Display Panel – 0.03 oz Pouch Label
Principal Display Panel – 0.03 oz Pouch Label

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55550-902-212025-04-21C16284748780-1d6a99b39-37ca-a426-e053-dadaa90af4c2Drug Facts
55550-902-212022-01-28C16284748780-1d6a99b39-37ca-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55550-902-21Burn Cream0.9 g in 1 POUCHCREAM0.93

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55550-902BURN CREAM (BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE) CREAM [TOTAL RESOURCES INTERNATIONAL]3Current NDC, Legacy NDC, 1 package rows20250507_b971cc41-fe23-4be3-9564-e46d55df1d68.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55550-90255550-902-21

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
benzalkonium chlorideF5UM2KM3W7ACTIB
lidocaine hydrochlorideV13007Z41AACTIR
aloe vera leafZY81Z83H0XIACT
alcohol3K9958V90MIACT
methylparabenA2I8C7HI9TIACT
mineral oilT5L8T28FGPIACT
paraffinI9O0E3H2ZEIACT
propylparabenZ8IX2SC1OHIACT
water059QF0KO0RIACT
petrolatum4T6H12BN9UIACT
white wax7G1J5DA97FIACT

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 HYDROCHLORIDETotal Resources Internationalb971cc41-fe23-4be3-9564-e46d55df1d682025-04-18WarningsExact identifier
ndc (package): 55550-902-21
ndc (product): 55550-902
ndc11 (package): 55550090221
spl id: cbe13d07-34ab-4156-a8cd-ab055385fc6d
spl set id: b971cc41-fe23-4be3-9564-e46d55df1d68

Reported adverse events (FAERS/openFDA)#

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