Burn Ease, 3.5g

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name: Burn Ease, 3.5g
Generic name: BURN EASE, 3.5G
Manufacturer: ProStat First Aid LLC
Product type: HUMAN OTC DRUG
SPL set ID: 004aa18f-3a97-f454-e063-6394a90afcff
SPL ID: 460100cc-1092-14d8-e063-6294a90a62fe
Version: 3
Effective date: 2025-12-15
Source export date: 2026-09-28
Source partition: 7
Source file: https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:46:32

Harmonized routes table
Harmonized routes
TOPICAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 11 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		Burn Ease, 3.5g	openfda.brand_name
generic name		BURN EASE, 3.5G	openfda.generic_name
manufacturer name		ProStat First Aid LLC	openfda.manufacturer_name
ndc	package	58228-3883-1	openfda.package_ndc
ndc	product	58228-3883	openfda.product_ndc
ndc11	package	58228388301	derived:openfda.package_ndc
rxcui		1011852	openfda.rxcui
spl id		460100cc-1092-14d8-e063-6294a90a62fe	id
spl set id		004aa18f-3a97-f454-e063-6394a90afcff	set_id
unii		V13007Z41A	openfda.unii

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For External Use Only. Do not use • On wounds or damaged skin • In large quantities, particularly over raw surfaces or blistered areas When using this product • Avoid contact with the eyes • Do not bandage tightly Stop use and ask a doctor if • 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. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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