FDA.reportPublic FDA data

DCH Cool and Heat Spray, 16% Menthol

Manufacturer
Derma Care Research Labs, LLC
Effective date
2025-01-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:53:48

Label at a glance#

ProductDCH Cool and Heat
Active ingredientMENTHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 16%

OTC - PURPOSE SECTION


Topical Analgesic

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pain associated with arthritis, simple backache, muscle strains, bruises, and sprains.

WARNINGS SECTION

For external use only. Flammable--Keep away from fire or flame. When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water, do not apply to wounds or damaged skin, and do not bandage tightly, do not use with a heating pad. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. . Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

INACTIVE INGREDIENT SECTION

Alcohol Denat., Glycerin, Propylene Glycol, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1430458menthol 16 % Topical SprayPSN2
1430458menthol 160 MG/ML Topical SpraySCD2
1430458menthol 16 % Topical SpraySY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72839-129-04DCH Cool and Heat113 g in 1 CANSPRAY1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72839-129DCH COOL AND HEAT (MENTHOL 16%) SPRAY [DERMA CARE RESEARCH LABS, LLC]2Current NDC, 1 package rows20250129_ff323282-612c-eaf8-e053-6394a90ab779.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72839-12972839-129-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MIACT

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
DCH Cool and HeatMENTHOL 16%Derma Care Research Labs, LLCff323282-612c-eaf8-e053-6394a90ab7792025-01-27WarningsExact identifier
ndc (package): 72839-129-04
ndc (product): 72839-129
ndc11 (package): 72839012904
spl id: 2cb64d9d-891e-1f6f-e063-6294a90a4760
spl set id: ff323282-612c-eaf8-e053-6394a90ab779

Reported adverse events (FAERS/openFDA)#

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