FDA.reportPublic FDA data

COOL BREEZE Pain Relief Gel

Manufacturer
COOL BREEZE US LLC
Effective date
2023-11-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:01:55

Label at a glance#

ProductCOOL BREEZE Pain Relief
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains.

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 Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 5.10%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

  • For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings:

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

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

  • rash or irritation develops and lasts.
  • condition worsens, or if symptoms persist for more than 7 days or 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 right away.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

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:

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Carbomer, Ethylhexylglycerin, Isopropyl Alcohol, Methyl Salicylate, Phenoxyethanol, Propylene Glycol, Sodium Hydroxide, FD&C Blue #1, FD&C Yellow #5.

Questions:

OTC - QUESTIONS SECTION

317-721-4699

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2669723menthol 5.1 % Topical GelPSN1
2669723menthol 0.051 MG/MG Topical GelSCD1
2669723menthol 5.1 % Topical GelSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72744-433-00COOL BREEZE Pain Relief118 mL in 1 TUBEGEL1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72744-433COOL BREEZE PAIN RELIEF (MENTHOL) GEL [COOL BREEZE US LLC]1Current NDC, 1 package rows20231114_14dcf4ee-6778-49d4-8601-9205737432ea.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72744-43372744-433-00

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
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ISOPROPYL ALCOHOLND2M416302IACT
METHYL SALICYLATELAV5U5022YIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM HYDROXIDE55X04QC32IIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
MENTHOLL7T10EIP3AACTIB

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
COOL BREEZE Pain ReliefMENTHOLCOOL BREEZE US LLC14dcf4ee-6778-49d4-8601-9205737432ea2023-11-01WarningsExact identifier
ndc (package): 72744-433-00
ndc (product): 72744-433
ndc11 (package): 72744043300
spl id: 09135640-d8a9-790c-e063-6294a90a8fce
spl set id: 14dcf4ee-6778-49d4-8601-9205737432ea

Reported adverse events (FAERS/openFDA)#

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