FDA.reportPublic FDA data

Harmony Hemp Flexible Pain Relief Spray 500

Manufacturer
Abacus Health Products, Inc. | Inspec Solutions
Effective date
2021-02-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:50:16

Label at a glance#

ProductHarmony Hemp Flexible Pain Relief Spray500
Active ingredientMENTHOL
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Menthol USP, 10.5%

OTC - PURPOSE SECTION

Menthol USP, 10.5% ................. Topical Analgesic

INDICATIONS & USAGE SECTION

temporary relief of minor aches and pain of muscles and joints associated with simple backache, arthritis, strains, bruises and 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 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.

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 occur again within a few days

USER SAFETY WARNINGS SECTION

Flammable: keep away from excessive heat or open flame

OTC - PREGNANCY OR BREAST FEEDING SECTION

Do not use if pregnant or breastfeeding.

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 immediately.

DOSAGE & ADMINISTRATION SECTION

adults and children over 12 years of age:

  • 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

children 12 years of age or younger: Ask a doctor.

INACTIVE INGREDIENT SECTION

alcohol denat., arnica montana flower extract, calendula officianalis flower extract, camellia sinensis leaf extract, chamomile recutita flower extract, dimethyl sulfone, echinacea angustifolia extract, ilex paraguariensis leaf extract, industrial hemp extract, isopropyl myristate, juniperus communis fruit extract, water

OTC - QUESTIONS SECTION

Questions or comments? 888-949-4367

RECENT MAJOR CHANGES SECTION

Uses and Directions

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73096-07673096-076-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CHAMOMILEFGL3685T2XIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
ECHINACEA ANGUSTIFOLIAVB06AV5US8IACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
HEMPTD1MUT01Q7IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
JUNIPER BERRYO84B5194RLIACT
WATER059QF0KO0RIACT
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
0d9a2510-81aa-6dfe-e063-6294a90acafcbc0b2e7e-9c8e-30cf-e053-2a95a90ac1982023-12-28WarningsExact identifier
spl set id: bc0b2e7e-9c8e-30cf-e053-2a95a90ac198

Reported adverse events (FAERS/openFDA)#

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