FDA.reportPublic FDA data

Harmony Hemp Flexible 10.4% Menthol Pain Relief Spray 1000mg

Manufacturer
Harmony Products LLC | Inspec Solutions LLC.
Effective date
2020-01-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:42:33

Label at a glance#

ProductHarmony Hemp Flexible 10.4% Menthol Pain Relief 1000mg
Active ingredientMENTHOL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Menthol 10.5%

OTC - PURPOSE SECTION

Menthol 10.4% ................. Topical Analgesic

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product, avoid contact with eyes and mucous membranes., do not apply to wound or damage skin, do not bandage, do not use with heating pad or device.

OTC - STOP USE SECTION

Stop use and ask a doctor if, condition worsens, 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

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

Harmony Hemp Flexible 10.4% Menthol Pain Relief Spray 1000mgHarmony Hemp Flexible 10.4% Menthol Pain Relief Spray 1000mg

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73096-05973096-059-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
FRANKINCENSER9XLF1R1WMIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
GLYCERINPDC6A3C0OXIACT
MELISSA OFFICINALIS LEAF50D2ZE9219IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
ARCTIUM LAPPA ROOT597E9BI3Z3IACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CAMPHOR (NATURAL)N20HL7Q941IACT
CARBOMER 9404Q93RCW27EIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
HEMPTD1MUT01Q7IACT
ISOPROPYL ALCOHOLND2M416302IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MENTHOLL7T10EIP3AACTIB

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
f100f60a-1104-5b3f-e053-2a95a90aa85495e5ad5c-892d-7b00-e053-2a95a90a6e792022-12-29WarningsExact identifier
spl set id: 95e5ad5c-892d-7b00-e053-2a95a90a6e79

Reported adverse events (FAERS/openFDA)#

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