Harmony Flexible 4% Menthol Pain Relief Roll-On 1000mg

Manufacturer
Harmony Products LLC. | Inspec Solutions LLC.
Effective date
2019-10-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:04:47

Label at a glance#

ProductHarmony Flexible 4% Menthol Pain Relief Roll-On 1000mg
Active ingredientMENTHOL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%

OTC - PURPOSE SECTION

Menthol 4% ...............Topical Analgesic

INDICATIONS & USAGE SECTION

Uses Temporary Relief from minor aches and pains of muscles and joints associated with, simple backache, strains, bruises, sprains

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product

Use only as directed, do not bandage tightly or use with 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.

OTC - STOP USE SECTION

Stop use and ask a doctor if, condition worsens, blistering or burning occurs, pain or swelling occurs, symptoms persist for more than 7 days or clear up and occur again within a few days.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 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

1000mg Flex Roll-On1000mg Flex Roll-On

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73096-04473096-044-01, 73096-044-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 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
f100b3d3-1d9a-fcc9-e053-2a95a90af45895af3f4c-0712-3394-e053-2a95a90ab1832022-12-29WarningsExact identifier
spl set id: 95af3f4c-0712-3394-e053-2a95a90ab183

Reported adverse events (FAERS/openFDA)#

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