FDA.reportPublic FDA data

DCH Cooling Pain Relief Gel, Menthol 4%

Manufacturer
Derma Care Research Labs, LLC
Effective date
2024-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:45:12

Label at a glance#

ProductDCH Cooling Pain Relief
Active ingredientMENTHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

OTC - PURPOSE SECTION

Topical Analgesic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only.

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin, do not bandage tightly, and do not use with heating pad.

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear and occur again within a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

• adults and children 12 years and older, apply to affected area not more than 3 to 4 times daily. • Children under 12 years old, ask a doctor

INACTIVE INGREDIENT SECTION

Blue 1, carbomer, isopropyl alcohol, magnesium sulfate, sodium hydroxide, water, yellow 5.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
415974menthol 4 % Topical GelPSN2
415974menthol 0.04 MG/MG Topical GelSCD2
415974menthol 4 % Topical GelSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72839-297-03DCH Cooling Pain Relief89 mL in 1 TUBEGEL892

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72839-297DCH COOLING PAIN RELIEF (MENTHOL 4%) GEL [DERMA CARE RESEARCH LABS, LLC]2Current NDC, 1 package rows20241222_00ed3175-c3ba-6545-e063-6394a90acfd1.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72839-29772839-297-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C BLUE NO. 1H3R47K3TBDIACT
MENTHOLL7T10EIP3AACTIB
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)132584PQMOIACT
WATER059QF0KO0RIACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
ISOPROPYL ALCOHOLND2M416302IACT
FD&C YELLOW NO. 5I753WB2F1MIACT
SODIUM HYDROXIDE55X04QC32IIACT

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 Cooling Pain ReliefMENTHOL 4%Derma Care Research Labs, LLC00ed3175-c3ba-6545-e063-6394a90acfd12024-12-19WarningsExact identifier
ndc (package): 72839-297-03
ndc (product): 72839-297
ndc11 (package): 72839029703
spl id: 29a5d178-edcc-5e44-e063-6394a90aa6a9
spl set id: 00ed3175-c3ba-6545-e063-6394a90acfd1

Reported adverse events (FAERS/openFDA)#

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