FDA.reportPublic FDA data

Harmony Neuro 4% Lidocaine Pain Relief 500mg

Manufacturer
Harmony Products LLC. | Inspec Solutions LLC.
Effective date
2020-02-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:41:43

Label at a glance#

ProductHarmony Hemp NeuroComfort 4% Lidocaine Pain Relief Roll-on 500mg
Active ingredientLIDOCAINE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Lidocaine HCl 4%

OTC - PURPOSE SECTION

Lidocaine HCl 4% ............. Topical Analgesic

INDICATIONS & USAGE SECTION

Uses Temporary Relief of pain

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

DO not use in large quantities over raw surfaces and blistered area.

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 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

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

Acrylates/C10-30 Alkyl Acrylate Crosspolymer

Aloe Barbadensis Leaf Extract

Aminomethyl Propanol

C30-45 Alkyl Cetearyl Dimethicone Crosspolymer

Caprylyl Methicone

Cetearyl Alcohol

Ceteth-20 Phosphate

Dicetyl Phosphate

Dimethicone

Disodium EDTA

Ethylhexylglycerin

Full Spectrum Industrial Hemp Extract

Glyceryl Stearate

Methylparaben

SD Alcohol 40

Steareth-21

Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Harmony Hemp NeuroComfort 4% Lidocaine Pain Relief Roll-on 500mgHarmony Hemp NeuroComfort 4% Lidocaine Pain Relief Roll-on 500mg

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73096-06273096-062-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
EDETATE DISODIUM7FLD91C86KIACT
ALCOHOL3K9958V90MIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
AMINOMETHYL PROPANEDIOLCZ7BU4QZJZIACT
C30-45 ALKYL METHICONENFX970DSI2IACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETETH-20 PHOSPHATE921FTA1500IACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
DIMETHICONE 100RO266O364UIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERYL STEARATE CITRATEWH8T92A065IACT
METHYLPARABENA2I8C7HI9TIACT
STEARETH-2153J3F32P58IACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
HEMPTD1MUT01Q7IACT
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
f1010ed2-5cbe-2903-e053-2995a90a30bf95db8b8b-8eda-a0ec-e053-2a95a90aa2752022-12-29WarningsExact identifier
spl set id: 95db8b8b-8eda-a0ec-e053-2a95a90aa275

Reported adverse events (FAERS/openFDA)#

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