FDA.reportPublic FDA data

Cooln Heat Muscle Rub

Manufacturer
Walgreens | Product Quest Mfg.
Effective date
2018-02-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:54:39

Label at a glance#

ProductCooln Heat Muscle Rub Well at Walgreens
Active ingredientMenthol
Label structure6 sections

Indications and uses

temporarily reliefs minor pain associated with • arthritis • simple backache •strains • bruises

Dosage and administration

​Adults and childern over 12 years: squeeze desired amount of pain relieving gel into painful area until throughly absorbed repeat as necessary, but not more than 4 times daily ​Children 12 years or younger: ​ ask a doctor

Label contents#

Full prescribing information#

Active ingredient                    Purpose

OTC - ACTIVE INGREDIENT SECTION

Menthol  2.5%                         Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily reliefs minor pain associated with • arthritis • simple backache •strains • bruises

WarningsFor external use only

WARNINGS SECTION

​When using this product​

  • use only as directed
  • do not bandage tightly or use use with heating pad
  • avoid contact with eyes or mucous membranes
  • do not apply to wounds or damaged, broken or irritated skin

Directions

DOSAGE & ADMINISTRATION SECTION

​Adults and childern over 12 years:

  • squeeze desired amount of pain relieving gel into painful area until throughly absorbed
  • repeat as necessary, but not more than 4 times daily

​Children 12 years or younger:​ ask a doctor

Inaction ingredients

INACTIVE INGREDIENT SECTION

Alcohol Denat.
Allantoin
Aloe Barbadensis Leaf Extract
Carbomer
DMDM Hydantoin
Glycerin
Methylparaben
Phenoxyethanol
Propylparaben
Steareth-2
Steareth-21
Triethanolamine
Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
282805menthol 2.5 % Topical GelPSN3
282805menthol 0.025 MG/MG Topical GelSCD3
282805menthol 2.5 % Topical GelSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-7002-032020-01-31C16284748780-19d75b9d0-94ea-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-7002-03Cooln Heat Muscle RubWell at Walgreens89 mL in 1 TUBEGEL893
0363-7002-03Cooln Heat Muscle RubWell at Walgreens1 in 1 CARTONGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-7002COOLN HEAT MUSCLE RUB WELL AT WALGREENS (MENTHOL) GEL [WALGREENS]3Legacy NDC, 2 package rows20180220_b7321ace-191b-4595-ab54-992310f83335.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-7002-03GM - Gram0363-7002ca357692-971c-4a2a-b65a-e4cc9605070112022-06-06

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-70020363-7002-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
MentholL7T10EIP3AACTIB
Alcohol3K9958V90MIACT
Allantoin344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
DMDM HydantoinBYR0546TOWIACT
GlycerinPDC6A3C0OXIACT
MethylparabenA2I8C7HI9TIACT
PhenoxyethanolHIE492ZZ3TIACT
PropylparabenZ8IX2SC1OHIACT
Steareth-2V56DFE46J5IACT
Steareth-2153J3F32P58IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

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
90ccedab-95dd-47d1-8cd8-7fccb00ff0deb7321ace-191b-4595-ab54-992310f833352018-02-20WarningsExact identifier
spl id: 90ccedab-95dd-47d1-8cd8-7fccb00ff0de
spl set id: b7321ace-191b-4595-ab54-992310f83335

Reported adverse events (FAERS/openFDA)#

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