FDA.reportPublic FDA data

PS-3831

Manufacturer
ProStat First Aid LLC
Effective date
2026-11-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
daily-update
Hydrated at
2026-11-07 03:01:37

Label at a glance#

ProductBurn Ease
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily • Children under 2 years of age: Consult a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine Hydrochloride 2%

Purpose

OTC - PURPOSE SECTION

Analgesic

Use(s)

INDICATIONS & USAGE SECTION

• For the temporary relief of pain associated with

• Minor burns

• Sunburn

Warnings

WARNINGS SECTION

For External Use Only

Do not use

OTC - DO NOT USE SECTION

• On wounds or damaged skin

• In large quantities, particularly over raw surfaces or blistered areas

When using this product

OTC - WHEN USING SECTION

• Avoid contact with the eyes

• Do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

• Condition worsens • Symptoms persist for more than 7 days • Symptoms clear up and occur again within a few days

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily

• Children under 2 years of age: Consult a doctor

Other Information

OTHER SAFETY INFORMATION

• Store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 alkyl acrylate crosspolymer, Carbomer, Glycerin, Imidazolidinyl urea, Methyparaben, Propylene glycol, Propylparaben, Purified water, Tea tree leaf oil, Triethamnolamine

Questions?

OTC - QUESTIONS SECTION

1-888-900-2920 8AM - 4PM PST

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PS_3831-BX-MASTERPS_3831-BX-MASTER3831 Burn Ease

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130814889014627GTIN-13: 0814889014627
EAN-13: 0814889014627
GTIN-12: 814889014627
UPC-A: 814889014627
GTIN storage (14 digits): 00814889014627		PS-3831-BX-MASTER-R230214-4.jpg

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 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58228-383158228-3831-1, 58228-3831-2

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
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
GLYCERINPDC6A3C0OXIACT
TEA TREE OILVIF565UC2GIACT
TROLAMINE9O3K93S3TKIACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
METHYLPARABENA2I8C7HI9TIACT
WATER059QF0KO0RIACT
IMIDUREAM629807ATLIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-12-15full-release2026-06-01 01:25:32

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 EaseBURN EASEProStat First Aid LLCf71b98b4-22d0-0124-e053-6394a90ae4cf2025-12-15WarningsExact identifier
ndc (package): 58228-3831-2
ndc (package): 58228-3831-1
ndc (product): 58228-3831
ndc11 (package): 58228383101
ndc11 (package): 58228383102
spl set id: f71b98b4-22d0-0124-e053-6394a90ae4cf

Reported adverse events (FAERS/openFDA)#

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