Cool and Heat Sore Muscle Roller

Manufacturer
Evora Worldwide | Inspec Solutions LLC
Effective date
2022-01-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:16:51

Label at a glance#

ProductCool and Heat Sore Muscle Roller Evora Labs
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

 temporarily relieves minor pain associated with: • arthritis • simple backache • muscle strains • sprains • bruises• cramps

Dosage and administration

adults and children over 12 years: • apply generously to affected area • massage into painful area until thoroughly absorbed into skin • repeat as necessary, but no more than 3 to 4 times daily • IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER Children 12 years or younger: ask a doctor

Label contents#

Full prescribing information#

Active ingredient                                               Purpose

OTC - ACTIVE INGREDIENT SECTION


Menthol 16% ..................................................... Topical analgesic

Uses

INDICATIONS & USAGE SECTION

 temporarily relieves minor pain associated with:
• arthritis • simple backache • muscle strains • sprains • bruises• cramps

Warnings

WARNINGS SECTION


For externa use only.
When using this product • use only as directed • do not
bandage tightly or use with a heating pad • avoid contact with
eyes and mucous membranes • do not apply to wounds or
damaged, broken or irritated skin • a transient burning sensation
may occur upon application but generally disappears in several
days • if severe burning sensation occurs, discontinue use
immediately • do not expose the area treated with product to heat
or direct sunlight

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
Flammable • keep away from fire or flame
If pregnant or breast-feeding, ask a health professional before
use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION


adults and children over 12 years: • apply generously to
affected area • massage into painful area until thoroughly
absorbed into skin • repeat as necessary, but no more than 3 to 4
times daily • IF MEDICINE COMES IN CONTACT WITH HANDS,
WASH WITH SOAP AND WATER
Children 12 years or younger: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate
Crosspolymer, Capsaicin, Glycerin, lsopropyl Myristate, Propylene
Glycol, SD Alcohol 40 (30%), Triethanolamine, Water

Questions?

OTC - QUESTIONS SECTION

1-888-793-8450

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77375-008-022025-12-11C16284748780-11030e364-f991-111a-e063-dadaa90a10e2Drug Facts
77375-008-022024-01-30C16284748780-11030e364-f991-111a-e063-dadaa90a10e2Drug Facts

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77375-008COOL AND HEAT SORE MUSCLE ROLLER EVORA LABS (MENTHOL) LIQUID [EVORA WORLDWIDE]3Legacy NDC20220115_c6d8c5cf-cd01-4469-96f0-2b4dceb828ae.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
77375-00877375-008-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
45aeadf7-f2bb-3104-e063-6394a90add73c6d8c5cf-cd01-4469-96f0-2b4dceb828ae2025-12-11WarningsExact identifier
spl set id: c6d8c5cf-cd01-4469-96f0-2b4dceb828ae

Reported adverse events (FAERS/openFDA)#

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