FDA.reportPublic FDA data

Harmony Hemp NeuroComfort Pain Relief Spray 500

Manufacturer
Abacus Health Products, Inc. | Inspec Solutions LLC
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 NeuroComfort Pain Relief Spray500
Active ingredientLIDOCAINE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Lidocaine HCl 4%

OTC - PURPOSE SECTION

Lidocaine HCl 4% .............Topical anesthetic

INDICATIONS & USAGE SECTION

temporary relief of pain

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use in large quantities, particularly over raw surfaces and blistered areas

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes and mucous membranes

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

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 2 years of age and older

  • Apply to affected area no more than 3 to 4 times daily
  • Wash hands with soap and water after use

children under 12 years of age: Ask a doctor

INACTIVE INGREDIENT SECTION

alcohol denat. aloe barbadensis leaf extract, carbomer, chamomilla recutita (matricaria) flower extract, cucumis sativus (cucumber) extract, diazolidinyl urea, disodium cocoamphodipropionate, disodium EDTA, glycerin, industrial hemp extract, propylene glycol, dimethicone, tocopheryl acetate, triethanolamine, water

OTC - QUESTIONS SECTION

Questions or comments? 888-949-4367

RECENT MAJOR CHANGES SECTION

Uses: temporary relief of pain

Directions:

adults and children 12 years of age and older

  • apply to affected area no more than 3 to 4 times daily
  • wash hands with soap and water after use

children under 12 years of age: Ask a doctor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Harmony Hemp

NeuroComfort

Pain Relief Spray

Continuous Spray

Lidocaine HCL 4%

Hands & Feet

CBD Moisturizing Oil

500mg per bottle

Net wt 4.5 oz (127 g)

11

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73096-07073096-070-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CHAMOMILEFGL3685T2XIACT
CUCUMBERYY7C30VXJTIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
DISODIUM COCOAMPHODIPROPIONATE6K8PRP397MIACT
WATER059QF0KO0RIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
GLYCERINPDC6A3C0OXIACT
HEMPTD1MUT01Q7IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIMETHICONE92RU3N3Y1OIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
LIDOCAINE98PI200987ACTIB

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
0d9a0c27-eec7-5ce2-e063-6294a90a90b0bc08b78c-54e5-8d0e-e053-2995a90ad7e92023-12-28WarningsExact identifier
spl set id: bc08b78c-54e5-8d0e-e053-2995a90ad7e9

Reported adverse events (FAERS/openFDA)#

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