myDerm Cooling Menthol Pain Relief Roll-On with 50 Percent More Menthol

Manufacturer
Inspec Solutions LLC.
Effective date
2025-01-31
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
legacy-cache
Hydrated at
2026-08-01 20:41:38

Label at a glance#

ProductmyDerm Cooling Menthol Pain Relief Roll-On with 50 Percent More Menthol
Active ingredientMENTHOL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Menthol 4%

OTC - PURPOSE SECTION

Menthol 4% ........... Topical analgesic

INDICATIONS & USAGE SECTION

Uses Temporary relief of pain

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

DO not use in large quantities over raw surfaces and blistered area

When using this product

Use only as directed, read and follow all directions and warnings on this label, rare cases of serious burn have been reported with product of this type, do not bandage tightly or apply local heat (such as heating pads) to the area of use or use with medicated patch, avoid contact with eyes and mucous membranes

OTC - STOP USE SECTION

Stop use and ask doctor if, condition worsens, redness is present, irritation develops, 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

Keep out of reach of children, if swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

adults and children 2 years of age and older: Apply to affected area no more than 3 to 4 times daily. Wash hands with soap. Children under 2 years of age: consult a doctor.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Aloe Barbadensis Leaf Extract

Arctium Lappa Root (Burdock) Extract

Arnica Montana Flower Extract

Boswellia Carterii Resin Extract

Calendula Officinalis Extract

Camellia Sinensis Leaf Extract

Camphor

Carbomer FD&C Blue #1

FD&C Yellow #5

Full Spectrum Industrial Hemp Extract

Glycerin

Ilex Paraguariensis (Mate) Leaf Extract

Isopropyl Alcohol

Isopropyl Myristate

Melissa Officinalis (Lemon Balm) Leaf Extract

Silica

Tocopheryl Acetate

Triethanolamine

Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

myDerm Cooling Menthol Pain Relief Roll-On with 50% More MentholmyDerm Cooling Menthol Pain Relief Roll-On with 50% More Menthol

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72667-022-012025-02-01C16284748780-12cef2736-6f74-d83d-e063-dadaa90ab31fmyDerm Cooling Menthol Pain Relief Roll-On with 50% More Menthol

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72667-022MYDERM COOLING MENTHOL PAIN RELIEF ROLL-ON WITH 50 PERCENT MORE MENTHOL (MENTHOL) GEL [INSPEC SOLUTIONS LLC.]11Legacy NDC20250202_d4284a1b-dd4f-6bf0-e053-2995a90a6c1e.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72667-02272667-022-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

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
4af417f1-6fae-be33-e063-6394a90a12f5d4284a1b-dd4f-6bf0-e053-2995a90a6c1e2026-02-16WarningsExact identifier
spl set id: d4284a1b-dd4f-6bf0-e053-2995a90a6c1e

Reported adverse events (FAERS/openFDA)#

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