Burn Relief Professional Bio-Kool

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 Relief Professional Bio-Kool
Generic name: LIDOCAINE - 4%
Manufacturer: Kool-Down Inc.
Product type: HUMAN OTC DRUG
SPL set ID: 827e9c69-4706-0ccf-e053-2991aa0aa1c1
SPL ID: 3893cf5b-7ca1-321b-e063-6294a90a9cb5
Version: 3
Effective date: 2025-06-27
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:25:53

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 · 14 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		M017	openfda.application_number
brand name		Burn Relief Professional Bio-Kool	openfda.brand_name
generic name		LIDOCAINE - 4%	openfda.generic_name
manufacturer name		Kool-Down Inc.	openfda.manufacturer_name
ndc	package	61566-201-04	openfda.package_ndc
ndc	package	61566-201-14	openfda.package_ndc
ndc	product	61566-201	openfda.product_ndc
ndc11	package	61566020104	derived:openfda.package_ndc
ndc11	package	61566020114	derived:openfda.package_ndc
rxcui		1421893	openfda.rxcui
rxcui		2118551	openfda.rxcui
spl id		3893cf5b-7ca1-321b-e063-6294a90a9cb5	id
spl set id		827e9c69-4706-0ccf-e053-2991aa0aa1c1	set_id
unii		98PI200987	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

For external use only. Do not use in large quantities, particularity over raw surfaces or blistered areas When using this product keep out of eyes, use only as directed Stop use and ask a doctor if condition worsens or symptoms last more than 7 days or clear up and occur again within a few days.

Reported adverse events (FAERS/openFDA)#

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