FDA.reportPublic FDA data

FIRST AID & BURN CREAM

Manufacturer
HART Health
Effective date
2026-04-15
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:53:48

Label at a glance#

ProductFirst Aid and Burn
Active ingredientBENZALKONIUM CHLORIDE, LIDOCAINE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients (in each gram):

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

OTC - PURPOSE SECTION

Purpose:

Topical Antiseptic

Topical Anesthetic

INDICATIONS & USAGE SECTION

Uses: Temporary relief of pain and to help prevent infection in

  • minor cuts
  • scrapes
  • burns

WARNINGS SECTION

Warnings: For external use only. See a doctor immediately for serious burns

OTC - DO NOT USE SECTION

Do not use:

  • in or near the eyes
  • over large portions of the body
  • in large quantities particularly over raw surfaces or blistered areas
  • longer than 7 days unless directed by a doctor
  • more than 1 to 3 times daily

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • serious burns
  • animal bites
  • deep or puncture wounds

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition lasts for more than 7 days
  • condition worsens
  • symptoms clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away. 1-800-222-1222

DOSAGE & ADMINISTRATION SECTION

Directions: do not use more than directed

Adults and children 2 years of age and over:

  • clean the affected area
  • apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily
  • may be covered with a sterile bandage

Children under 2 years of age: ask a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients: 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, sodium hydroxide.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5391 First aid-Burn cream H&B v24f-Small.jpg5391 First aid-Burn cream H&B v24f-Small.jpgHB 0351 First Aid & Burn Cream Unit v25Small_Jpeg.jpgHB 0351 First Aid & Burn Cream Unit v25Small_Jpeg.jpgHB 0350 First Aid & Burn Cream Unit 10 per v25_Small_Jpeg.jpgHB 0350 First Aid & Burn Cream Unit 10 per v25_Small_Jpeg.jpg

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
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

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50332-009150332-0091-2, 50332-0091-1, 50332-0091-6, 50332-0091-4, 50332-0091-9

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
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
LIDOCAINE98PI200987ACTIB
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
CETEARYL ALCOHOL2DMT128M1SIACT
DISODIUM HEDTAKME849MC7AIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
MALTODEXTRIN7CVR7L4A2DIACT
MINERAL OILT5L8T28FGPIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARIC ACID4ELV7Z65APIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT

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 and BurnBENZALKONIUM CHLORIDE, LIDOCAINEHART Health07d447f1-469c-4e34-b807-ede9a449e6ab2026-04-15WarningsExact identifier
ndc (package): 50332-0091-6
ndc (package): 50332-0091-1
ndc (package): 50332-0091-9
ndc (package): 50332-0091-2
ndc (package): 50332-0091-4
ndc (product): 50332-0091
ndc11 (package): 50332009104
ndc11 (package): 50332009101
ndc11 (package): 50332009102
ndc11 (package): 50332009109
ndc11 (package): 50332009106
spl id: 98a02c61-1ac2-4788-93e9-a3b574960c9e
spl set id: 07d447f1-469c-4e34-b807-ede9a449e6ab

Reported adverse events (FAERS/openFDA)#

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