Cool and Heat Sore Muscle Roller

Manufacturer
Acutens
Effective date
2024-11-05
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
legacy-cache
Hydrated at
2026-08-01 20:50:22

Label at a glance#

ProductCool and Heat Sore Muscle Roller
Active ingredientMENTHOL
Label structure7 sections

Indications and uses

Temporary relief of minor aches pains of muscles and joints associated with arthritis, simple backache, strains, bruises, and sprains

Label contents#

Full prescribing information#

Active ingredients                               Purpose

OTC - ACTIVE INGREDIENT SECTION

Menthol 16%                                       Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

Temporary relief of minor aches pains of muscles and joints associated with arthritis, simple backache, strains, bruises, and sprains

Warnings For external use only

WARNINGS SECTION

Flammable: Keep away from fire or flame.

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 •symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If accidentally ingested get medical help or contact a Poison Control Center immediately

Direction

DOSAGE & ADMINISTRATION SECTION


• Adults and children 2 years of age and older: apply to affected area not more than 3-4 times daily
• Children under 2 years old: consult apfysician

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer
Capsaicin
Glycerin
Isopropyl Myristate
Propylene Glycol
SD Alcohol 40 (30.0%)
Triethanolamine
Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80551-002COOL AND HEAT SORE MUSCLE ROLLER (MENTHOL) GEL [ACUTENS]7Legacy NDC20241107_f76069df-1c8f-4e96-bceb-d838c654c6eb.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
80551-00280551-002-02

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
458579ee-49e6-d45d-e063-6294a90a7d77f76069df-1c8f-4e96-bceb-d838c654c6eb2025-12-09WarningsExact identifier
spl set id: f76069df-1c8f-4e96-bceb-d838c654c6eb

Reported adverse events (FAERS/openFDA)#

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