Burn Relief Extra Strength Kool-Down

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 Extra Strength Kool-Down
Generic name: LIDOCAINE - 3.9%
Manufacturer: Kool-Down Inc
Product type: HUMAN OTC DRUG
SPL set ID: 827fec2f-db3c-adbb-e053-2a91aa0a7c17
SPL ID: 386fb699-0ea0-e203-e063-6294a90a78e7
Version: 3
Effective date: 2025-06-25
Source export date: 2026-10-27
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/2026-10-27/be847f9aea8d80a2cb7e9771acd1143be084664192ecf8f5be8ac1024116f4f0/drug-label-0007-of-0014.json.zip
Source manifest SHA-256: 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run: 20261027T193451Z
Imported at: 2026-10-27 20:13:39

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 Extra Strength Kool-Down	openfda.brand_name
generic name		LIDOCAINE - 3.9%	openfda.generic_name
manufacturer name		Kool-Down Inc	openfda.manufacturer_name
ndc	package	61566-279-14	openfda.package_ndc
ndc	package	61566-279-04	openfda.package_ndc
ndc	product	61566-279	openfda.product_ndc
ndc11	package	61566027914	derived:openfda.package_ndc
ndc11	package	61566027904	derived:openfda.package_ndc
rxcui		2108920	openfda.rxcui
rxcui		2108915	openfda.rxcui
spl id		386fb699-0ea0-e203-e063-6294a90a78e7	id
spl set id		827fec2f-db3c-adbb-e053-2a91aa0a7c17	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

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.