FDA.reportPublic FDA data

Walgreens Cool and Heat Menthol Spray

Manufacturer
Walgreens
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:42:35

Label at a glance#

ProductWalgreens Cool and Heat
Active ingredientMENTHOL
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 16%

OTC - PURPOSE SECTION

Topical analgesic

INDICATIONS & USAGE SECTION

Temporarily alleviates minor aches and pains of muscles and joints associated with Arthritis, Simple Backache, Strains, Bruises, or Sprains

WARNINGS SECTION

For external use only.

Flammable: Do not use while smoking or near heat or flames. Avoid long term storage above 104°F. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120°F.

OTC - WHEN USING SECTION

Avoid contact with eyes and mucous membranes.

Do not apply to wounds or damaged skin. Do not bondage tightly. Use only as directed.

OTC - ASK DOCTOR SECTION

Stop use and ask doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days. Do not use for longer than 1 week.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

If pregnant or breast- feeding, ask a health professional before use.

DOSAGE & ADMINISTRATION SECTION

Shake well- adult and children 12 year of age and older: spray product on affected area, not more than 3 to 4 times daily.

Children under 12 years of age: consult a doctor.

INACTIVE INGREDIENT SECTION

Glycerin, Isobutane, Propylene Glycol, SD Alcohol 40B, Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1430458menthol 16 % Topical SprayPSN3
1430458menthol 160 MG/ML Topical SpraySCD3
1430458menthol 16 % Topical SpraySY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-3031-04Walgreens Cool and Heat113 g in 1 BOTTLE, SPRAYAEROSOL, SPRAY1133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-3031WALGREENS COOL AND HEAT (MENTHOL 16%) AEROSOL, SPRAY [WALGREENS]3Current NDC, 1 package rows20241213_ce1585f4-ca65-8d0c-e053-2995a90a8e89.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-30310363-3031-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
DEHYDRATED ALCOHOL3K9958V90MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
ISOBUTANEBXR49TP611IACT
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
Walgreens Cool and HeatMENTHOL 16%Walgreensce1585f4-ca65-8d0c-e053-2995a90a8e892024-12-11WarningsExact identifier
ndc (package): 0363-3031-04
ndc (product): 0363-3031
ndc11 (package): 00363303104
spl id: 28f0f222-183f-2fdc-e063-6394a90a7023
spl set id: ce1585f4-ca65-8d0c-e053-2995a90a8e89

Reported adverse events (FAERS/openFDA)#

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