FDA.reportPublic FDA data

Burn Spray

Manufacturer
HART Health
Effective date
2024-01-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:07:36

Label at a glance#

ProductBurn
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Lidocaine HCL 2%

OTC - PURPOSE SECTION

Purpose:

Topical Anesthetic

INDICATIONS & USAGE SECTION

Uses:

Temporary pain relief of minor burns

WARNINGS SECTION

Warnings

For external use only

See a doctor immediately or 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
  • on serious burns
  • longer than 7 days unless directed by a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens
  • condition lasts for more than 7 days
  • 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:

Adults and children 12 years of age and over:

  • clean the affected area
  • apply to the affected area not more than 3 to 4 times dailys
  • may be covered with a sterile bandage when dry

Children under 12 years of age: ask a doctor

OTHER SAFETY INFORMATION

store at 68° to 77°F (20-25°C)

INACTIVE INGREDIENT SECTION

Inactive Ingredients

aloe vera, germaben II, propylene glycol, purified water 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2728Burnv23f.jpg2728Burnv23f.jpg

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
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50332-0210-1Burn60 mL in 1 BOTTLE, SPRAYSPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50332-0210BURN (LIDOCAINE) SPRAY [HART HEALTH]1Current NDC, 1 package rows20240119_e95ebdac-9789-41c2-97da-2307e4538794.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50332-021050332-0210-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
ALOE VERA WHOLEKIZ4X2EHYXIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
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
BurnLIDOCAINEHART Healthe95ebdac-9789-41c2-97da-2307e45387942024-01-18WarningsExact identifier
ndc (package): 50332-0210-1
ndc (product): 50332-0210
ndc11 (package): 50332021001
spl id: 9a0381b0-0a7d-4eae-9684-63bc260e41f8
spl set id: e95ebdac-9789-41c2-97da-2307e4538794

Reported adverse events (FAERS/openFDA)#

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