FDA.reportPublic FDA data

Be Smart Get Prepared Burn Cream

Manufacturer
Total Resources International, Inc
Effective date
2024-08-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-09-01 13:02:59

Label at a glance#

ProductBe Smart Get Prepared Burn Cream
Active ingredientBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUS
Label structure8 sections

Indications and uses

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

Dosage and administration

clean affected area apply small amount not more than 3 times daily may be covered with a sterile bandage

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

  • Benzalkonium Chloride 0.13% w/w
  • Lidocaine HCl 0.5% w/w

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

Topical Analgesic

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

OTC - DO NOT USE SECTION

  • 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

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 directly.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean affected area
  • apply small amount not more than 3 times daily
  • may be covered with a sterile bandage

Other Information

OTHER SAFETY INFORMATION

  • store at room temperature
  • tamper evident sealed packets
  • do not use any opened or torn packets

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, cetearyl alcohol, disodium EDTA, ethylhexylglycerin, glycerin, glyceryl stearate, mineral oil, palmitic acid, PEG-100 stearate, phenoxyethanol, propylene glycol, sodium hydroxide, stearic acid, water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BE SMART
GET PREPARED®
BURN CREAM

net wt.: 0.03 oz [0.90 g]

Single use only ● Do not use if package is torn

Made in China
Manufactured for Total Resources Intl. Inc.
Walnut, California 91789
www.besmartgetprepared.com

00-BUR-0011HB Rev.00 NDC# 55550-521-01

Principal Display Panel
Principal Display Panel

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

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
55550-52155550-521-01

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
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
LIDOCAINE HYDROCHLORIDE ANHYDROUSEC2CNF7XFPACTIB
ALOE VERA LEAFZY81Z83H0XIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
MALTODEXTRIN7CVR7L4A2DIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARIC ACID4ELV7Z65APIACT
MINERAL OILT5L8T28FGPIACT
SODIUM HYDROXIDE55X04QC32IIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12024-08-16full-release2026-06-01 00:17:39

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
Be Smart Get Prepared Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUSTotal Resources International, Inceacb5138-4af8-4550-b883-5603ad96ed7d2024-08-16WarningsExact identifier
ndc (package): 55550-521-01
ndc (product): 55550-521
ndc11 (package): 55550052101
spl id: 19ae996c-122d-43ef-8068-a257ad604f75
spl set id: eacb5138-4af8-4550-b883-5603ad96ed7d

Reported adverse events (FAERS/openFDA)#

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