FDA.reportPublic FDA data

Dermachange Cold Therapy Gel, Menthol 2%

Manufacturer
Private Label Beauty and Wellness | Derma Care Research Labs, LLC
Effective date
2024-03-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:09:25

Label at a glance#

ProductDermachange Cold Therapy
Active ingredientMENTHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 2%

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.

Do not use with other topical pain relievers, with heating pad or heating devices.

When using this product do not use in or near the eyes, do not apply to wounds or damaged skin, do not bandage tightly.

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

Ammonium hydroxide, blue 1, carbomer, copper PCA, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
311502menthol 2 % Topical GelPSN1
311502menthol 0.02 MG/MG Topical GelSCD1
311502menthol 2 % Topical GelSY1
311502menthol 2 % topical stickSY1

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
83520-131-08Dermachange Cold Therapy227 g in 1 JARGEL2271

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83520-131DERMACHANGE COLD THERAPY (MENTHOL) GEL [PRIVATE LABEL BEAUTY AND WELLNESS]1Current NDC, 1 package rows20240307_12ef7dd8-3da3-9c87-e063-6394a90ac924.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
83520-13183520-131-08

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
AMMONIA5138Q19F1XIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
WATER059QF0KO0RIACT
MENTHOLL7T10EIP3AACTIB
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)132584PQMOIACT
COPPER PIDOLATE497G7G1SL1IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
ISOPROPYL ALCOHOLND2M416302IACT
THYMOL3J50XA376EIACT
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
Dermachange Cold TherapyMENTHOLPrivate Label Beauty and Wellness12ef7dd8-3da3-9c87-e063-6394a90ac9242024-03-05WarningsExact identifier
ndc (package): 83520-131-08
ndc (product): 83520-131
ndc11 (package): 83520013108
spl id: 12ef7dd8-3da2-9c87-e063-6394a90ac924
spl set id: 12ef7dd8-3da3-9c87-e063-6394a90ac924

Reported adverse events (FAERS/openFDA)#

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