FDA.reportPublic FDA data

Burn Relief Extra Strength

Manufacturer
Kool-Down Inc | CGI Packaging, LLC
Effective date
2019-01-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:58:13

Label at a glance#

ProductBurn Relief Extra Strength Kool-Down
Active ingredientLIDOCAINE
Label structure8 sections

Indications and uses

Temporarily relieves pain due to: burns insect bites itching

Dosage and administration

Adults and children 5 years of age and older: apply to affected area not more that 3-4 times daily. Children under 5 years of age: ask a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine - 3.9%

Purpose

OTC - PURPOSE SECTION

Topical Pain Reliever

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 right away.

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves pain due to:

  • burns
  • insect bites
  • itching

Warnings

WARNINGS SECTION

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
• symptoms last more than 7 days or clear up and occur again within a few days.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 5 years of age and older: apply to affected area not more that 3-4 times daily. Children under 5 years of age: ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice

Glycerin

Stearic Acid

Glyceryl Stearate SE

Isopropyl Myristate

Ethoxydiglycol

Ozokerite

Polysorbate 80

Carbomer

Zinc Oxide

Allantoin

Ascorbic Acid

Methylparaben

Diazolidinyl Urea

Propylparaben

Triethanolamine

Tetrasodium EDTA

Tocopheryl Acetate

Prunus Amygdalus Dulcis (Sweet Almond) Oil

Canola Oil

Fragrance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2108920Kool-Down 3.9 % Topical CreamPSN2
2108915lidocaine 3.9 % Topical CreamPSN2
2108920lidocaine 39 MG/ML Topical Cream [Kool-Down]SBD2
2108915lidocaine 39 MG/ML Topical CreamSCD2
2108920Kool-Down 3.9 % Topical CreamSY2
2108920Kool-Down 39 MG/ML Topical CreamSY2
2108915lidocaine 3.9 % Topical CreamSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61566-117-042020-09-27C16284748780-1ab0e2407-2e94-f274-e053-dbdaa90a64717f991c90-b505-445c-e053-2991aa0a99c7
61566-117-042020-09-25C16284748780-1ab0e2407-2e94-f274-e053-dbdaa90a64717f991c90-b505-445c-e053-2991aa0a99c7
61566-117-042020-07-22C16284748780-1ab0e2407-2e94-f274-e053-dbdaa90a64717f991c90-b505-445c-e053-2991aa0a99c7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61566-117-04Burn Relief Extra StrengthKool-Down113 g in 1 BOTTLECREAM1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61566-117BURN RELIEF EXTRA STRENGTH KOOL-DOWN (LIDOCAINE - 3.9%) CREAM [KOOL-DOWN INC]2Legacy NDC, 1 package rows20190117_7f991c90-b505-445c-e053-2991aa0a99c7.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61566-11761566-117-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOEV5VD430YW9IACT
GLYCERINPDC6A3C0OXIACT
STEARIC ACID4ELV7Z65APIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
CERESINQ1LS2UJO3AIACT
POLYSORBATE 806OZP39ZG8HIACT
CARBOXYPOLYMETHYLENE0A5MM307FCIACT
ZINC OXIDESOI2LOH54ZIACT
ALLANTOIN344S277G0ZIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
METHYLPARABENA2I8C7HI9TIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
PROPYLPARABENZ8IX2SC1OHIACT
TROLAMINE9O3K93S3TKIACT
EDETATE SODIUMMP1J8420LUIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALMOND OIL66YXD4DKO9IACT
CANOLA OIL331KBJ17RKIACT
LIDOCAINE98PI200987ACTIB

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
7f9a4b20-4614-3b00-e053-2a91aa0a06587f991c90-b505-445c-e053-2991aa0a99c72019-01-16WarningsExact identifier
spl id: 7f9a4b20-4614-3b00-e053-2a91aa0a0658
spl set id: 7f991c90-b505-445c-e053-2991aa0a99c7

Reported adverse events (FAERS/openFDA)#

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